Breast Cancer
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Jun 01 – Jun 08, 2026
Fovinaciclib for First-Line Therapy of Advanced Breast Cancer: A Randomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This double-blind, phase 3 randomized clinical trial evaluated the efficacy and safety of fovinaciclib combined with aromatase inhibitors as first-line therapy for hormone receptor-positive, ERBB2-negative advanced breast cancer. Enrolled between March 2022 and June 2023, 417 adult women were randomized 1:1 to receive fovinaciclib or placebo with letrozole/anastrozole; premenopausal patients also received goserelin. At an interim analysis with a median follow-up of 16.6 months, fovinaciclib significantly improved median progression-free survival (not reached vs. 20.2 months; HR, 0.55; 95% CI, 0.38-0.77; 1-sided P < .001) with consistent benefits across subgroups, manageable hematologic adverse effects, and no significant quality-of-life differences. These findings suggest clinically meaningful benefits for using fovinaciclib in this population, though overall survival data remain immature.
10.1001/jamaoncol.2026.1938
A Randomized Phase III Trial of Anthracyclines Followed by Taxane versus Taxane Plus Carboplatin as (Neo)Adjuvant Therapy in Patients with Triple-Negative Breast Cancer: KCSG BR 15-1 PEARLY Trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The PEARLY trial, a randomized phase 3 study, evaluated the efficacy and safety of adding carboplatin to standard anthracycline/taxane chemotherapy in 868 patients with early-stage triple-negative breast cancer (TNBC) across 22 institutions in Korea. Patients were randomized to receive either standard therapy (doxorubicin/cyclophosphamide followed by taxane) or the same regimen plus carboplatin, with primary endpoint of event-free survival (EFS). At median 57.2-month follow-up, carboplatin significantly improved EFS (HR=0.67, 95% CI: 0.49-0.92, P=0.012), with 5-year EFS rates increasing from 75.1% to 82.3% (absolute 7.2% difference), though secondary endpoints (OS, IDFS, DRFS) showed non-significant trends favoring carboplatin. The study concluded that carboplatin addition significantly improved EFS in early TNBC despite higher grade ≥3 adverse events (74.7% vs 56.7%), with maintained quality of life supporting its favorable risk-benefit profile.
10.1016/j.annonc.2026.05.703
May 25 – Jun 01, 2026
Impact of patient-reported taxane-induced peripheral neuropathy on dose reductions or worsening quality of life in Black women with breast cancer: Analysis from ECOG-ACRIN EAZ171.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This study, based on the prospective ECOG-ACRIN EAZ171 trial, evaluated the impact of taxane-induced peripheral neuropathy (TIPN) on dose reductions and health-related quality of life (HRQOL) in 239 Black women with breast cancer receiving (neo)adjuvant taxane. Patient-reported outcomes (PROs) assessed TIPN using the FACT-GOG/NTx scale, while HRQOL and physical function were measured using FACT-G and PROMIS PF-10a through 12 months. TIPN was common and significantly predicted taxane dose reductions, with the FACT-GOG/NTx 4-item subscale showing the strongest association (OR, 10.8; 95% CI, 4.5-25.9). Persistent TIPN was linked to worse HRQOL (OR, 5.05; 95% CI, 1.33-19.17) and physical function (OR, 5.29; 95% CI, 1.57-17.83) at 12 months; results emphasize the importance of early intervention for TIPN and its implications for equitable breast cancer treatment outcomes.
10.1002/cncr.70466
Tumor flare-like response: A novel imaging phenomenon with predictive significance in triple negative breast cancer patients undergoing neoadjuvant immuno-chemotherapy.
BREAST · Q1 JOURNAL - RANK #4/140
This ad hoc imaging analysis of a prospective phase II trial (NCT04213898; n=39) investigated tumor flare-like response (TFLR) on breast MRI in triple-negative breast cancer patients undergoing neoadjuvant immuno-chemotherapy. TFLR occurred in 74.4% of patients and completely resolved in 75.9% by treatment completion; median persistence was 152 days. Largest nodule diameter ≥9 mm independently predicted pathological complete response (pCR) in multivariable analysis (OR=7.833, 95% CI 1.260-48.701, P=.027), while TFLR presence alone did not (P=.72). The authors conclude TFLR is a frequent, reversible MRI finding and that nodule size ≥9 mm is a promising early imaging biomarker of immunotherapeutic efficacy.
10.1016/j.breast.2026.104823
Concordance between clinician-reported toxicities and patient-reported symptom severity in early-stage breast cancer: an analysis of the randomized phase III PANTHER trial.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This study examined concordance between clinician-reported toxicities and patient-reported symptom severity during adjuvant chemotherapy for early-stage breast cancer, using data from the randomized phase III PANTHER trial. Clinician toxicities were graded via CTCAE v3.0, and patient symptoms via EORTC QLQ-C30 and BR23 questionnaires at mid- and end-of-treatment. Among 1566 patients, weighted Cohen’s kappa showed low agreement across all six symptoms (kappa = 0.07–0.34), with highest discrepancy for fatigue (36%–54%) and pain (23%–38%). The authors concluded that concordance is poor and increases over time, advocating for routine inclusion of patient-reported assessments.
10.1016/j.esmoop.2026.107696
Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
The SOLTI-1802 ONAWA trial was a single-arm prospective clinical trial examining preoperative, extended-release onapristone (ONA-XR, 50 mg BID for 21 days) in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer. The primary objective was to assess changes in tumor proliferation; ONA-XR suppressed proliferation, with a Ki-67 geometric mean change of -17.78% (CI95 -39.76% to 12.20%) and greater effect in tumors with PgR≥90% (-46.21%; CI -63.02% to -21.76%). Immunohistochemical analyses confirmed molecular pathway effects, and 60% of participants experienced adverse events. The trial concludes ONA-XR is active in suppressing early tumor proliferation, warranting further clinical evaluation.
10.1038/s41523-025-00887-9
Intrathecal Allogeneic B7-H3-targeted CAR γδ T Cells for Leptomeningeal Metastasis from Solid Tumors: Safety, Efficacy, and Immunological Dynamics in a Phase 1 Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
Phase 1 trial NCT06592092 evaluated intrathecal QH104, an allogeneic B7-H3–targeted CAR γδ T-cell therapy, in three patients with B7-H3–positive leptomeningeal metastases from lung adenocarcinoma (n=2) or triple-negative breast cancer (n=1). Patients received 3 × 10^7 cells per infusion via lumbar puncture or Ommaya reservoir; primary endpoint was clinical response, with safety, overall survival, quality of life, and PK/PD as secondary endpoints. QH104 was generally well tolerated (no grade ≥4 TRAEs; one grade 3 ICANS resolving with care), all patients achieved stable disease at days 14 and 30 with symptom improvement in two, and CSF cytology converted and remained negative to day 30 in one baseline-positive case. CAR γδ T cells persisted in CSF for at least one week with increased IFN-γ, and single-cell sequencing indicated IFN-γ–associated immune remodeling.
10.1158/1078-0432.CCR-26-0738
Safety analyses of the INAVO120 randomised phase III trial of inavolisib or placebo with palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This randomized phase III clinical trial evaluated the safety profile of inavolisib plus palbociclib-fulvestrant versus placebo plus palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer. Active interventions included defined oral and intramuscular dosing schedules, with adverse events graded per NCI CTCAE v5.0 and managed by supportive medications. Hyperglycaemia led to inavolisib dose interruptions in 27.2% of patients and discontinuations in 0.6%, with similar reporting for rash, stomatitis, and diarrhoea; management strategies involved clinically indicated therapy such as metformin, hydrocortisone, dexamethasone mouthwash, and loperamide. The study concluded the safety profile was generally consistent, manageable, and tolerable, and adverse events were reversible with appropriate treatment.
10.1016/j.esmoop.2026.107735
Durvalumab Plus Paclitaxel, with or without Capivasertib or Oleclumab, in Patients with Locally Advanced/Metastatic Triple-Negative Breast Cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase Ib/II, multiarm, platform study (BEGONIA) evaluated durvalumab plus paclitaxel with or without capivasertib or oleclumab as first-line treatment for locally advanced unresectable/metastatic triple-negative breast cancer (mTNBC). The primary objective was safety and tolerability; secondary endpoints included objective response rate (ORR). Confirmed ORR was 56.5% for durvalumab plus paclitaxel (n=23), 54.8% for capivasertib combination (n=31), and 51.5% for oleclumab combination (n=33). The authors conclude that durvalumab plus paclitaxel shows clinical activity, but adding capivasertib or oleclumab provided no substantial additional benefit.
10.1158/1078-0432.CCR-25-4417
NeoCircle: pre- and post-operative circulating tumor DNA dynamics predicts survival in neoadjuvant-treated early breast cancer.
EMBO MOL MED · Q1 JOURNAL - RANK #21/195
The study evaluated the predictive value of circulating tumor DNA (ctDNA) dynamics in 136 early breast cancer patients undergoing neoadjuvant treatment (NAT) from the prospective SCAN-B study (NCT02306096). Using a personalized tumor-informed digital PCR approach, baseline ctDNA detection was 89.7%, with end-NAT positivity (21.4%) and non-response (13.1%) significantly predicting disease recurrence and death, outperforming pathologic complete response. Post-operative ctDNA detection was associated with distant recurrence (median lead-time 13.8 months). The findings support the clinical utility of structural variants as a minimal residual disease analyte in breast cancer.
10.1038/s44321-026-00447-z
Sensitivity to endocrine therapy index predicts benefit from weekly adjuvant paclitaxel for hormone receptor-positive breast cancer in the GEICAM/9906 trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This prospective-retrospective biomarker study within the GEICAM/9906 trial (NCT00129922) compared adjuvant FEC followed by weekly paclitaxel versus six cycles of FEC in lymph node-positive breast cancer. Among 567 evaluable HR+/HER2- tumor samples, the SETER/PR index was measured with a pre-specified cutpoint (<0.75), identifying 92 tumors (16.2%) with low endocrine transcriptional activity. A significant interaction between SETER/PR status and treatment on distant recurrence-free interval was observed (p=0.046), with low-index patients benefiting from paclitaxel (HR 0.46; 95% CI, 0.22-0.95; p=0.035), while no benefit was seen for high-index patients (HR 1.02; 95% CI, 0.70-1.47; p=0.931). The authors conclude that low endocrine transcriptional activity independently validates the SETER/PR index as a predictive biomarker for paclitaxel benefit in HR+/HER2- breast cancer.
10.1158/1078-0432.CCR-26-0177
May 18 – May 25, 2026
Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The BEGONIA study is a phase Ib/II, open-label clinical trial assessing the safety and efficacy of datopotamab deruxtecan (Dato-DXd) combined with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Arms 7 and 8 of the study evaluated patients with different PD-L1 tumor expression levels receiving Dato-DXd (6 mg/kg) and durvalumab (1120 mg) every three weeks. In Arm 7 (n=62), the confirmed objective response rate (cORR) was 79.0%, with a median duration of response (DoR) of 17.6 months. In Arm 8 (n=33), the cORR was 81.8%, although DoR and progression-free survival (PFS) data were immature due to shorter follow-up. The combination demonstrated promising antitumor activity with a manageable safety profile.
10.1016/j.annonc.2026.05.693
Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This multicenter, open-label, randomized phase 3 trial evaluated fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer patients after first-line chemotherapy response or disease control. 210 patients were randomized equally to the two treatment groups, with a median follow-up of 33.6 months. Fulvestrant significantly improved progression-free survival (PFS) compared to capecitabine (17.3 vs. 9.0 months, hazard ratio 0.63, p=0.003), while grade ≥3 adverse events were lower in the fulvestrant group (2.9% vs. 10.5%). The study concludes that fulvestrant offers superior PFS and a favorable safety profile for maintenance therapy in this patient population.
10.1038/s41392-026-02720-6
Cardiac Radiation Dose and Subclinical Coronary Artery Disease Progression after Breast Cancer Radiotherapy: 2-year Cardiac CT Results from the EARLY-HEART Study.
RADIOL-CARDIOTHORAC · Q1 JOURNAL - RANK #30/212
This secondary analysis of the prospective multicenter EARLY-HEART study evaluated 224 asymptomatic female breast cancer patients treated with radiation therapy post-lumpectomy, using cardiac CT scans before and 24 months after treatment. The study assessed cardiac radiation dose and progression of coronary artery calcium (CAC), finding that higher cardiac radiation doses were associated with increased CAC progression (whole heart relative risk: 2.0 [95% CI: 1.5, 2.8]; p < .001) at 2-year follow-up, particularly among those with baseline calcification. Coronary stenosis progression, observed in 36 patients, did not correlate with cardiac radiation dose but was linked to higher baseline CACS and CAC progression (p < .001). The authors conclude that cardiac radiation dose is a predictor of subclinical coronary artery disease progression post-breast cancer radiotherapy.
10.1148/ryct.250342
Longitudinal transcriptomic profiling identifies predictors of response to neoadjuvant chemoimmunotherapy in triple-negative breast cancer: results from the NeoTRIPaPDL1 trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The NeoTRIPaPDL1 phase III randomized trial enrolled 280 patients with high-risk triple-negative breast cancer, assigning them to neoadjuvant chemotherapy with or without atezolizumab. Longitudinal biopsies were collected for transcriptomic profiling, and associations between gene signatures and pathologic complete response (pCR) were evaluated via logistic regression and XGBoost models. Key findings include higher baseline tumor proliferation and lower stromal/metabolic signatures correlating with increased pCR in the chemoimmunotherapy arm, while early on-treatment immune activation and tumor clearance strongly predicted pCR across both arms. The principal conclusion is that dynamic gene expression changes and early tumor clearance are robust predictors of pCR, supporting adaptive neoadjuvant strategies for TNBC.
10.1016/j.annonc.2026.05.694
Cryoablation for early-stage invasive breast cancer: pathologic and imaging outcomes from the prospective FIRST trial.
BREAST CANCER RES · Q1 JOURNAL - RANK #57/326
The prospective, multicenter, single-arm phase II FIRST trial aimed to determine the pathological efficacy and safety of ultrasound-guided cryoablation for early-stage invasive breast cancer, correlate imaging and pathology, and identify technical predictors for successful tumor ablation. Forty-eight patients with unifocal tumors ≤2.5 cm were treated, followed by surgical resection 14-28 days post-cryoablation. The invasive complete ablation rate was 97.9%, 100% for tumors ≤2.0 cm, with high negative predictive value for MRI (93.0%), limited residual ductal carcinoma in situ in 12.5%, and minimal adverse events. Cryoablation showed promise as a safe and effective minimally invasive approach but remains investigational, requiring phase III trials to define its role in breast-conserving strategies.
10.1186/s13058-026-02302-y
Economic evaluation of lymphaticovenous anastomosis versus conservative therapy for breast-cancer related lymphoedema: secondary outcome analysis of a randomized controlled trial.
BJS-BRIT J SURG · Q1 JOURNAL - RANK #5/312
This study is a pre-specified secondary outcome analysis of a randomized controlled trial evaluating the cost-effectiveness of lymphaticovenous anastomosis (LVA) combined with complex decongestive therapy (CDT) versus CDT alone for breast cancer-related lymphoedema. The trial included 100 female patients from four Dutch hospitals and adopted a societal perspective with a 2-year time horizon, deriving Quality-Adjusted Life Years from the EuroQol-5D-5L. Mean total costs were €16,234 (LVA) vs €14,293 (CDT) with an adjusted mean difference of €78, while mean QALYs were 1.636 vs 1.579 with an adjusted difference of 0.045, yielding a societal ICER of €1,716/QALY. The authors conclude that LVA combined with CDT has potential to be cost-effective from a societal perspective, particularly when performed under local anaesthesia.
10.1093/bjs/znag062
Exploratory analysis of PTEN deficiency by immunohistochemistry from the Phase III CAPItello-291 trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This study aimed to explore the utility of immunohistochemistry (IHC) for identifying PTEN deficiency in hormone receptor-positive/HER2-negative advanced breast cancer, using samples from the Phase III CAPItello-291 clinical trial. PTEN IHC was performed on 367 tumor samples, with 19.1% classified as PTEN deficient; concordance between IHC and next-generation sequencing (NGS) results was 87.0% overall. Among PTEN-deficient cases, patients receiving capivasertib plus fulvestrant showed improved progression-free survival compared to placebo plus fulvestrant (median 9.3 vs 3.7 months; hazard ratio: 0.52, 95% CI: 0.28-0.90). The principal conclusion is that IHC may help identify patients eligible for capivasertib plus fulvestrant treatment based on PTEN status.
10.1158/1078-0432.CCR-25-2965
A chemotherapy-free, pathological response-adapted strategy using trastuzumab-pertuzumab and T-DM1 in HER2-positive early breast cancer: the PHERGain-2 study.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This multicenter, single-arm, phase II study evaluated a pCR-guided de-escalation strategy to omit chemotherapy in 396 treatment-naive patients with HER2-positive, node-negative early breast cancer. Patients received neoadjuvant trastuzumab-pertuzumab (HP), with endocrine therapy for hormone receptor-positive tumors, followed by adjuvant HP for pCR (cohort A, 59.6%) or T-DM1 for residual disease (cohort B, 37.8%; cohort C, 1.8%). One-year global HRQoL decline ≥10% occurred in 42.8% overall (37.3% pCR vs. 51.9% residual disease), with 86.6% treatment-related adverse events (5.6% grade ≥3) and one death from pneumonitis. PHERGain-2 demonstrated meaningful HRQoL preservation, expected toxicity, and an outstanding pCR rate comparable to standard chemotherapy plus HP regimens.
10.1016/j.annonc.2026.01.013
Survival Analysis of the WSG TP-II Trial: Neoadjuvant Trastuzumab and Pertuzumab Plus Endocrine Therapy Versus Chemotherapy in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The WSG TP-II trial (NCT03272477) was a multicenter, randomized phase II open-label study comparing 12-week neoadjuvant trastuzumab + pertuzumab with endocrine therapy (ET) versus chemotherapy (paclitaxel) in 207 hormone receptor-positive/HER2-positive early breast cancer patients. The primary endpoint showed superior pathologic complete response (pCR) rates in the chemotherapy arm (56.4% vs. 23.7%), with 5-year survival analysis revealing 100% overall survival (ET arm) versus 97.9% (chemotherapy arm) and invasive disease-free survival rates of 97.7% versus 79.8%. The study demonstrated excellent survival outcomes for both de-escalated chemotherapy and ET approaches with dual HER2 blockade. WSG TP-II confirms the safety and efficacy of pCR-guided adjuvant therapy in this patient population.
10.1200/JCO-25-01047
Twenty-year results of the randomized European Organization for Research and Treatment of Cancer trial 22922/10925 evaluating internal mammary chain and medial supraclavicular lymph node irradiation in stage I-III breast cancer.
CA-CANCER J CLIN · Q1 JOURNAL - RANK #1/326TOP-TIER
Randomized EORTC 22922/10925 tested whether internal mammary and medial supraclavicular nodal irradiation (IM-MS-RT) improves outcomes in stage I–III breast cancer with axillary involvement and/or central/medial tumors, assigning 4004 patients (1996–2004) to IM-MS-RT or no IM-MS-RT; median follow-up 22.2 years. At 20 years, overall survival was 61.8% (control) vs 61.0% (IM-MS-RT; HR 1.00, p=.967), disease-free survival 49.0% vs 48.2% (HR 0.97, p=.515), and distant metastases-free survival 59.8% vs 58.9% (HR 0.97, p=.578). Breast cancer mortality was reduced (22.4% vs 18.6%; HR 0.82, p=.006), but deaths not from breast cancer/unknown were higher (15.8% vs 20.4%; HR 1.26, p=.002); toxicities increased with IM-MS-RT (lung fibrosis 6.3% vs 3.2%, cardiac fibrosis 2.7% vs 1.7%, cardiac diseases 15.2% vs 11.7%; severe cardiac 1.9% vs 1.7%, severe lung 0.3% vs 0.0%). IM-MS-RT lowered breast cancer mortality but conferred no long-term overall survival benefit, emphasizing the need for very long-term follow-up.
10.3322/caac.70082
Definitive, stereotactic ablative radiotherapy and endocrine therapy without surgery for select low-risk breast cancers: A prospective, phase II trial.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This prospective phase II trial (NCT02945579) tested stereotactic ablative radiotherapy (SABR) plus endocrine therapy (ET) as non-operative treatment for HR+, HER2– cT1N0M0 breast cancer, using 3 months of ET, SABR in five fractions, and vacuum-assisted core biopsy at 6–12 months; co-primary endpoints were pathologic complete response (pCR) and 3-year progression-free survival (PFS). Twenty patients (median age 70.5) were enrolled; 19 were biopsied, with pCR in 10/19 (53%, 95% CI 30–73%) and near-complete response in 7 (37%). Twelve patients omitted surgery and, with median follow-up 44.9 months, had 3-year PFS 92% (95% CI 54–99%), one non–breast cancer death, and no breast cancer recurrences; patient-reported decisional regret and breast-specific outcomes remained stable. The authors conclude SABR plus ET achieves substantial pCR and encouraging tumor control, supporting further evaluation of surgery omission in carefully selected patients.
10.1016/j.radonc.2026.111573
May 11 – May 18, 2026
Carboplatin with or without nivolumab in metastatic triple-negative breast cancer: a randomized phase II trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This multi-institutional, randomized, open-label phase II trial (NCT03414684) prospectively assigned 75 chemotherapy-naïve patients with metastatic triple-negative breast cancer to receive carboplatin plus nivolumab or carboplatin alone. Primary outcome was progression-free survival (PFS) in a modified intention-to-treat cohort (n = 62), with secondary endpoints of overall survival (OS), objective response, clinical benefit, and safety; correlative biomarker analyses were also performed. Median PFS was 4.2 months for the combination versus 5.5 months for carboplatin, and median OS was 16.8 versus 11.1 months, respectively; among PD-L1–positive patients (n = 24), PFS was 8.3 versus 4.7 months and OS 17.6 versus 10.7 months favoring the combination. The study concluded that adding nivolumab to carboplatin did not significantly improve PFS overall but showed a favorable trend in PD-L1–positive patients, with grade ≥3 adverse events in 56.8% and 65.8% of the combination and control arms, respectively.
10.1038/s41467-026-73085-1
Validation of the ESTRO target volume consensus guideline for early-stage breast cancer in the DBCG Skagen Trial 1.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This study prospectively validated the 2015 ESTRO target volume delineation guideline in early-stage breast cancer within the interventional DBCG Skagen Trial 1. In this trial, 2,963 patients (2,908 intention-to-treat) receiving adjuvant loco-regional radiotherapy had clinical target volumes contoured per the ESTRO guideline, and loco-regional recurrences (LRR) were prospectively captured and classified relative to the ESTRO-defined CTVs. After a median 5.2 years (IQR 4.1–6.7), 78 LRR occurred (41 isolated; 37 with concurrent distant), with 74/78 (95%) located within the CTVs; all local recurrences were within CTVp and all but three regional recurrences were within CTVn, with only three marginal misses. The authors conclude that LRR occurred almost exclusively within ESTRO-defined target volumes, supporting the guideline without need for modification.
10.1016/j.radonc.2026.111594
AI-powered and manual assessment of tumor-infiltrating lymphocytes in early HER2-positive breast cancer in NSABP B-41.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
The study aimed to evaluate tumor-infiltrating lymphocytes (TILs) and gene expression signatures (GES) in HER2-positive breast cancer using AI-based and manual methods. This prospective analysis included 262 patients from the randomized, phase III NSABP B-41 trial, assessing HER2-targeted therapies with chemotherapy. Key findings included an association between higher manual TILs and pathologic complete response (pCR) in ER-negative patients, while AI-based TILs and immune GES (iGES) showed respective associations with pCR and marginal associations with event-free survival (EFS). The results suggest TIL and iGES assessment as prognostic biomarkers, with further studies recommended to explore predictive utility in guiding treatment decisions.
10.1038/s41523-026-00961-w
Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 10-year efficacy and late normal tissue effects from a multicentre, open-label, non-inferiority, phase 3, randomised controlled trial and 5-year efficacy results from a randomised axillary substudy.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
The FAST-Forward trial compared a 1-week (26 Gy or 27 Gy in five fractions) versus 3-week (40 Gy in 15 fractions) adjuvant radiotherapy schedule for early-stage breast cancer in a multicentre, open-label, phase 3 randomised controlled trial involving 4087 patients. At 10-year follow-up, ipsilateral breast recurrence rates were 3.6% (40 Gy), 2.9% (27 Gy), and 2.1% (26 Gy), with 26 Gy showing comparable normal tissue effects (14.4% vs 13.1% for 40 Gy). A substudy (n=466) with 5-year follow-up reported 32 locoregional recurrences, supporting 26 Gy as a safe and efficacious standard. The study concludes that 26 Gy in five fractions over 1 week is non-inferior to the standard 3-week regimen for breast or chest wall radiotherapy.
10.1016/S1470-2045(26)00076-8
Doublecortin-Like Kinase 1 Expression in HER2-Positive Breast Cancer: Relation to Clinicopathological Characteristics and Response to Subcutaneous Injection of Pertuzumab-Trastuzumab (Phesgo) as a Part of Neoadjuvant Chemotherapy.
PATHOL INT · Q1 JOURNAL - RANK #19/90
This prospective study evaluated DCLK1 expression and response to neoadjuvant subcutaneous Pertuzumab-Trastuzumab (Phesgo) in 104 HER2-positive breast cancer patients. Pathologic complete response (pCR) occurred in 62.5% of patients and was associated with older age, negative lymph node status, and low DCLK1 expression. High DCLK1 expression (46.2%) correlated with larger tumor size, grade III tumors, lymph node metastasis, high Ki-67, and poor neoadjuvant response. Phesgo was tolerable without cardiac toxicity, and pCR with low DCLK1 expression predicted better overall and progression-free survival.
10.1111/pin.70119
Mammographic surveillance in breast cancer patients aged 50 years or older: a synopsis of the Mammo-50 RCT.
HEALTH TECHNOL ASSES · Q1 JOURNAL - RANK #30/185
This is a prospective, multicenter, randomized phase III clinical trial (Mammo-50 RCT) evaluating annual versus less-frequent mammography in 5,235 women aged ≥50 with early breast cancer, 3 years post-curative surgery, across 114 UK NHS hospitals. Coprimary outcomes were breast cancer-specific survival and cost-effectiveness, with secondary outcomes including recurrence-free interval and overall survival. At median 5.7-year follow-up, breast cancer-specific survival was 98% in both arms (HR 0.92, 95% CI 0.64-1.32), demonstrating non-inferiority of less-frequent mammography at 1% and 3% margins, with significant cost savings (mean £544-£1,543 per person). The authors conclude that less-frequent mammograms are non-inferior and cost-effective, supporting guideline updates, though note limitations in generalizability to younger, non-White, or ductal carcinoma in situ populations.
10.3310/GJJD0722
Concurrent Versus Sequential Radiation Dose Escalation to the Surgical Cavity for Conservative Treatment of High-Risk Early Breast Cancer: NRG/RTOG 1005 Phase III Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase III randomized clinical trial compared concurrent versus sequential radiation boost delivery to the surgical cavity during breast conservation for high-risk early breast cancer. Patients (n = 2,354; 2,255 eligible) were assigned to either a sequential boost after whole-breast irradiation (WBI) or a concurrent boost during WBI, and followed for a median of 7.3 years. The concurrent arm achieved noninferior ipsilateral breast recurrence (IBR) rates at 5 and 7 years (1.9% and 2.6%) compared to the sequential arm (2.1% and 2.2%) with hazard ratio 1.31 (90% CI: 0.84–2.04; noninferiority p = .037); adverse events and cosmetic outcomes were similar. The authors concluded concurrent boost reduces treatment time without increased toxicity or worsened outcomes.
10.1200/JCO-25-02465
Impact of Tamoxifen Only after Lumpectomy for “Good Risk” Duct Carcinoma in Situ: Combined Analysis of the NRG Oncology/RTOG 9804 and ECOG-ACRIN E5194 Trials.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This study aimed to evaluate the impact of tamoxifen use on ipsilateral breast recurrence (IBR) in ‘good risk’ ductal carcinoma in situ (DCIS) patients treated with lumpectomy alone by combining cohorts from two prospective clinical trials: NRG/RTOG 9804 and ECOG-ACRIN E5194. Using exploratory analysis of a merged dataset (n=878), with a median follow-up of 14.85 years, the study compared recurrence rates by tamoxifen use employing univariate and multivariable Fine-Gray regression. Tamoxifen use was associated with a significant reduction in 15-year IBR (11.4% vs. 19.0%, p=0.001), and reduced risk for invasive IBR (HR=0.43, 95% CI: 0.24–0.77, p=0.0042). The principal conclusion is that tamoxifen significantly lowers IBR, particularly invasive recurrences, in good-risk DCIS patients managed with lumpectomy alone.
10.1016/j.ijrobp.2026.04.103
Carbon-Ion Radiation Therapy as Nonsurgical Treatment for Early-Stage Breast Cancer: 5-Year Results From the Phase 2 Part of the First Prospective Clinical Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
The study evaluated the long-term efficacy, safety, and cosmetic outcomes of carbon-ion radiation therapy (C-ion RT) as a nonsurgical treatment for early-stage breast cancer in a prospective phase 1/2 trial. Twelve patients aged ≥60 years with stage I, ER-positive, HER2-negative invasive ductal carcinoma ≤2 cm received C-ion RT (60 Gy in 4 fractions) plus adjuvant aromatase inhibitors, with a median follow-up of 73 months. Results showed a 100% complete response rate, 92% 5-year local control and disease-free survival, and 100% overall survival, with minimal toxicity (grade 1 AEs only). The study concluded that C-ion RT is a promising nonsurgical alternative for selected patients, warranting further investigation.
10.1016/j.ijrobp.2025.10.020
May 04 – May 11, 2026
Safely Stopping Premedications in Patients Receiving Paclitaxel: A Randomized Trial.
J NATL COMPR CANC NE · Q1 JOURNAL - RANK #17/326TOP-TIER
This prospective, randomized trial aimed to determine if discontinuing prophylactic medications for paclitaxel-induced hypersensitivity reactions is safe in patients with breast cancer. Ninety-eight patients who experienced no iHSRs during the first two doses of paclitaxel were randomized to continue or discontinue standard premedications, with 89 patients ultimately evaluable. Only one patient (2.3%) in the discontinuation arm experienced an iHSR, compared to none in the control arm, with significantly less sleep disturbance (0.5 vs 1.7; P=.002) and decreased appetite stimulation (1.0 vs 2.5; P=.0018) in the investigational group. Discontinuation was associated with minimal hypersensitivity risk and fewer steroid-associated side effects, suggesting a safe and more tolerable approach for selected patients.
10.6004/jnccn.2025.7475
The ARTEMIS trial identifies immune activation as a key predictor of neoadjuvant chemotherapy response in triple-negative breast cancer.
BREAST CANCER RES · Q1 JOURNAL - RANK #57/326
This prospective, randomized ARTEMIS trial (NCT02276443) enrolled patients with early-stage triple-negative breast cancer to evaluate whether a molecular classifier could predict response to neoadjuvant doxorubicin-cyclophosphamide (AC) chemotherapy and to characterize biological correlates of response. Participants were stratified by a molecular test and treated with AC; pathological complete response (pCR) after therapy served as the primary outcome, and tumor gene-expression and immune markers were profiled. Integrating the classifier modestly raised pCR from 33 % to 41 % (p = 0.43), while immune-based stratification revealed three subtypes: “immune hot sensitive” (50 % pCR), “immune hot resistant,” and “immune cold” (8 % pCR); immune cold tumors showed mesenchymal, FGF, and TGF-β signatures linked to chemoresistance. The study concludes that intratumoral immune activation strongly predicts AC response in TNBC, suggesting immune contexture–guided personalization or de-escalation of chemotherapy.
10.1186/s13058-026-02290-z
Night-time compression with a Mobiderm® auto-adjustable arm-sleeve in addition to daytime compression was superior to daytime compression alone for maintenance therapy of upper limb lymphedema in breast cancer patients in a randomized controlled trial: LYMphoNIGHT study.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
This multicenter randomized controlled trial (RCT) evaluated night-time compression with a Mobiderm® auto-adjustable arm-sleeve plus daytime compression versus daytime compression alone for maintenance therapy of upper limb breast cancer-related lymphedema (BCRL). Fifty-six women with BCRL who completed intensive decongestive therapy were randomized to the MobA group (night sleeve + daytime compression) or Control group (daytime compression alone) for three months. The primary outcome showed a 29.2% mean reduction in arm excess volume in the MobA group versus a 10.7% increase in controls (p=0.001), with significantly better quality of life, sleep, and skin measures in the MobA group. The study concluded that adding night-time compression was superior to daytime compression alone for reducing lymphedema volume.
10.1007/s00520-026-10735-6
Favorable safety outcomes of a perioperative propranolol and etodolac regimen in cancer patients in four randomized controlled trials.
FRONT PHARMACOL · Q1 JOURNAL - RANK #51/352
This study describes four small prospective, randomized controlled trials of perioperative propranolol and etodolac in 148 breast, colorectal, and pancreatic cancer patients. The regimen started 5 days before surgery and continued up to 30 days postoperatively, with propranolol titrated from 20 mg b.i.d to 80 mg b.i.d on surgery day and similarly adjusted later, while 400 mg b.i.d of etodolac was maintained. The primary endpoints were perioperative safety outcomes (AEs up to 30 days and 16 blood indices), showing manageable side effects such as bradycardia (12% in treated) and some changes in blood markers that did not remain significant after FDR correction. The secondary outcome indicated an improvement in 8-year DFS for CRC patients (2/15 vs. 9/18, p=0.034), suggesting the potential long-term efficacy of this combination therapy.
10.3389/fphar.2026.1823113
Endoxifen for mammographic density reduction-results from the KARISMA endoxifen trial.
JNCI-J NATL CANCER I · Q1 JOURNAL - RANK #44/326
This double-blind, randomized, placebo-controlled trial aimed to measure the effect of 1 mg and 2 mg of (Z)-endoxifen on mammographic breast density (MBD) in healthy premenopausal women over 6 months. Among 240 participants, MBD decreased significantly compared to placebo by -19.3% (95% CI=-6.15% to -32.4%) in the 1 mg arm and -26.5% (95% CI=-14.1% to -38.9%) in the 2 mg arm. Both doses were generally well tolerated, although 2 mg was associated with higher discontinuation rates and more vasomotor symptoms. These results suggest that 1 mg of (Z)-endoxifen shows similar effectiveness to 20 mg of tamoxifen with fewer side effects, warranting further studies to confirm its impact on breast cancer incidence.
10.1093/jnci/djag087
Apr 27 – May 04, 2026
Factors associated with arm swelling in patients undergoing surgery and radiotherapy for breast cancer within the FAST-Forward trial nodal sub-study.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This prospective analysis within the FAST-Forward nodal sub-study evaluated predictors of long-term arm/hand swelling in 469 breast cancer patients randomized to three radiotherapy regimens following surgery. DICOM-RT data collection was prospective, while dosimetric and key anatomical factors were assessed retrospectively; univariable and multivariable logistic regression analyzed associations with 5-year arm swelling. At 5 years, moderate/marked arm swelling was patient-reported in 13% (39/299), while clinician-reported lymphoedema occurred in 13% (45/346); axillary lymph node dissection (ALND) significantly predicted swelling (OR 3.70, 95% CI [1.61-8.48], p = 0.002), along with high BMI and positive nodes. The study concludes ALND is the principal modifiable risk for lymphoedema, supporting less invasive surgery to reduce long-term morbidity.
10.1016/j.radonc.2026.111547
Nivolumab Plus Ipilimumab in Patients With Solid Tumors With High Tumor Mutation Burden: Results From the Targeted Agent and Profiling Utilization Registry Study.
JCO PRECIS ONCOL · Q1 JOURNAL - RANK #57/326
This phase II basket trial (TAPUR) evaluated nivolumab plus ipilimumab in advanced cancer patients with high tumor mutation burden (≥10 mut/Mb). Three cohorts were enrolled: colorectal cancer (CRC, N=12), breast cancer (BC, N=13), and other solid tumors (HP, N=26). Disease control (DC) at ≥16 weeks was the primary endpoint; DC rates were 33% (BC) and 32% (HP), significantly exceeding the null rate of 15%, while the CRC cohort failed to meet the threshold. The authors conclude N+I demonstrated antitumor activity in BC and HP cohorts but not CRC.
10.1200/PO-25-01205
Health-related quality of life with pertuzumab retreatment: Secondary analysis of the PRECIOUS trial.
BREAST · Q1 JOURNAL - RANK #4/140
This study explores the impact of pertuzumab retreatment on health-related quality of life (HRQoL) as a secondary analysis of the randomized, open-label phase III PRECIOUS trial. Women with HER2-positive advanced breast cancer were randomized 1:1 to receive pertuzumab, trastuzumab, and chemotherapy (PTC) or trastuzumab and chemotherapy (TC), with HRQoL assessed via the FACT-B questionnaire. Results demonstrated no significant differences between groups in the primary endpoint, time-to-deterioration (TTD) in the B-TOI score (hazard ratio: 1.22; 95% CI: 0.86–1.90; p = 0.23), or in secondary TTD endpoints. The authors conclude that pertuzumab retreatment does not significantly affect HRQoL, supporting its use in appropriately selected patients with advanced HER2-positive breast cancer.
10.1016/j.breast.2026.104790
Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This single-centre, open-label, phase 1b trial explored the safety of combining ipatasertib (an AKT inhibitor) with endocrine therapy plus or minus palbociclib in refractory HR+/HER2- metastatic breast cancer. The study included 77 women with prior disease progression on multiple lines of treatment, and the recommended phase 2 dose was set at 400 mg ipatasertib and 100 mg palbociclib plus standard fulvestrant 500 mg. Median progression-free survival was 5.5 months (95% CI 3.8-7.4), and serious adverse events included leukopenia, neutropenia, thrombocytopenia, and hyperglycemia. These results underscore the potential clinical benefit of ipatasertib in combination with endocrine therapy and palbociclib for CDK4/6 inhibitor-resistant disease.
10.1016/S1470-2045(26)00059-8
Chemotherapy-Induced Nausea and Vomiting in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy With Fluorouracil, Epirubicin, Cyclophosphamide Followed by Docetaxel Versus an Anthracycline-Free Regimen With Docetaxel, Cyclophosphamide-Results From a Randomized Clinical Trial.
INT J CANCER · Q1 JOURNAL - RANK #77/326
This randomized controlled trial compared the incidence of chemotherapy-induced nausea and vomiting (CINV) in early breast cancer patients receiving two different chemotherapy regimens: FEC (5-fluorouracil, epirubicin, cyclophosphamide followed by docetaxel) versus TC (docetaxel, cyclophosphamide). The study involved 1582 participants who completed CINV diaries, with nausea and vomiting monitored hourly over three chemotherapy cycles. Patients receiving FEC experienced significantly higher nausea/emesis rates compared to TC, with 0-12h nausea-free/emesis-free rates of 70%/41% for FEC versus 91%/76% for TC in the first cycle (p<0.05). These findings highlight the importance of regimen selection and exemplify modern methodologies for CINV analysis in future therapeutics development, such as antibody-drug conjugates.
10.1002/ijc.70528
A Randomized, Phase II Clinical Trial of FLT-PET and FDG-PET for Early Response Assessment of Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase II trial assessed whether FDG or FLT PET/CT could forecast early response to neoadjuvant chemotherapy in stage II-III triple negative breast cancer. Twenty-two patients were randomized to either FDG or FLT imaging in Part A, which measured baseline, repeat, and post-cycle-1 scans to evaluate test-retest repeatability. After FDG emerged superior for image quality, the study found ΔSUVmax/mean after one cycle significantly correlated with mid-treatment MRI and end-of-treatment residual cancer burden (p < 0.005). FDG-PET findings were also linked to TIL changes, suggesting early metabolic reduction as a reliable predictor of histological response, warranting larger confirmatory trials.
10.1158/1078-0432.CCR-26-0041
Imlunestrant with or without abemaciclib in advanced breast cancer: safety analyses from the EMBER-3 trial.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
The EMBER-3 trial was a prospective randomized clinical study in patients with ER+, HER2- advanced breast cancer who had recurred or progressed on/after endocrine therapy, comparing imlunestrant and imlunestrant plus abemaciclib against standard endocrine therapy and each other. The abstract reports detailed safety analyses, including incidence, severity, timing, and management of treatment-emergent adverse events (TEAEs), and subgroup comparisons by age and treatment. Key findings: imlunestrant prolonged progression-free survival (PFS) versus standard ET in ESR1-mutated patients, imlunestrant + abemaciclib improved PFS vs imlunestrant (overall population); TEAEs were mostly low grade, reversible, occurred early, with discontinuation rates of 5% (imlunestrant) and 6% (combination), and dose adjustments in 61% for combination therapy. The study concludes that both oral therapies are effective and have a favorable, manageable safety profile.
10.1038/s41523-026-00950-z
Apr 20 – Apr 27, 2026
Phase I study of stereotactic ablative radiotherapy (SABR) in inoperable breast cancer.
BREAST · Q1 JOURNAL - RANK #4/140
This single-center phase I clinical trial evaluated stereotactic ablative radiotherapy (SABR) in elderly patients (≥70 years) with inoperable or surgery-refusing T1-2N0 M0-1 breast cancer. Using a Fibonacci 3+3 dose-escalation design to test 36 Gy, 38 Gy, and 40 Gy (in 5 fractions), the primary aim was to establish safety, tolerability, and the maximum tolerated dose (MTD). Over a median follow-up of 27 months (range: 4-40 months), 10 patients (11 tumors) experienced no dose-limiting toxicities. Local control (100%), progression-free survival (90%), and overall survival (90%) at 24 months suggest excellent safety, tolerability, and preliminary efficacy for SABR, warranting further investigation in phase II studies.
10.1016/j.breast.2026.104787
Durvalumab in Combination With Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer: Long-Term Analysis From the GeparNuevo Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The randomized phase II GeparNuevo trial tested durvalumab added to neoadjuvant nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide in early triple-negative breast cancer (cT1b–cT4a-d). A total of 174 patients were assigned to durvalumab or placebo and followed a median 86.4 months, with analyses stratified by baseline stromal tumor-infiltrating lymphocytes. Durvalumab improved iDFS (HR 0.56, 95% CI 0.32–0.99; p=0.0431), DDFS (HR 0.41, 95% CI 0.21–0.80; p=0.0069), and OS (HR 0.33, 95% CI 0.14–0.79; p=0.0085); nodal-positive patients had greater iDFS benefit (HR 0.33, 95% CI 0.144–0.771; p=0.01). Post hoc, sTIL-high (>10%) residual disease had 7-year iDFS 92.3% (95% CI 56.6–98.9) vs 51.4% (95% CI 29.2–69.7) for sTIL-low; the authors conclude durvalumab plus NACT improves long-term outcomes without adjuvant continuation.
10.1200/JCO-25-02311
Feasibility and safety of repeat breast-conserving surgery with intraoperative irradiation for local breast carcinoma recurrences: A phase 2 trial.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
The RE-IORT phase II trial assessed the feasibility and safety of repeat breast-conserving surgery (BCS) with intraoperative radiotherapy (IOReIrr) for local breast carcinoma recurrences in a prospective, multicenter, single-arm design. Eligible patients had low-risk, unifocal T1N0 recurrences ≥5 years post-radiotherapy, with primary endpoints focusing on grade ≥2 breast fibrosis at 12 months and secondary endpoints including local relapse-free survival and mastectomy-free rates. At 12 months, 90.6% (95% CI: 79.3-96.9) of 53 analyzed patients avoided grade ≥2 fibrosis, with 36-month and 60-month local recurrence-free survival rates of 96.8% (95% CI: 85.2-99.0) and 81.2% (95% CI: 65.2-90.3), respectively. The study concluded that IOReIrr during second BCS is feasible and safe for selected patients, offering a viable alternative to mastectomy.
10.1016/j.radonc.2026.111538
Apr 13 – Apr 20, 2026
Clinical and molecular biomarkers for prediction of endocrine response after short preoperative endocrine therapy in the WSG ADAPT-HR+/HER2- and ADAPTcycle trials (N=7914).
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The study investigates the predictors of endocrine therapy (ET) response in HR+/HER2- early breast cancer (eBC) patients by analyzing data from the WSG ADAPT-HR+/HER2- and ADAPTcycle trials. Using a cohort of 7,914 patients, the study evaluated the effect of ET regimens, including aromatase inhibitors (AI) and tamoxifen, with or without ovarian function suppression (OFS), on ET-response predictors such as Ki67, recurrence score (RS), and estrogen receptor expression, associating these with long-term outcomes like 5-year distant disease-free survival (dDFS). Results showed higher ET-response rates with AIs (81.4%-76.7%) compared to tamoxifen (40.1%-34.7%), improved further by OFS in premenopausal patients. The findings suggest that combining ET-response and gene expression assessments can personalize treatment by minimizing chemotherapy in luminal eBC patients, especially when treatment choice rather than biology accounts for differences in response.
10.1016/j.annonc.2026.04.007
Acute circulating tumor DNA dynamics during and after systemic therapy initiation for advanced triple-negative breast cancer.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
This single-arm prospective clinical trial in 14 patients with advanced triple-negative breast cancer examined acute changes in circulating tumor DNA (ctDNA) tumor fraction after initiation of systemic therapy. Patients received onalespib on day −7, paclitaxel on day 1, and combined onalespib + paclitaxel on day 8, with 313 plasma samples collected pre-infusion and at multiple time points up to day 9; ctDNA was quantified by shallow whole-genome sequencing. A significant decline in ctDNA tumor fraction was observed from pre-infusion to 6 h post-paclitaxel (p = 0.03) and from baseline to day 9 (median 16% to 6.5%, p = 0.004), while no immediate surge was detected within minutes to 24 h for any drug or combination. The investigators conclude that ctDNA levels fall rapidly during the first treatment cycle and that early ctDNA dynamics warrant further study as a pharmacodynamic marker.
10.1038/s41523-026-00953-w
HDAC inhibitor tucidinostat and metronomic capecitabine plus endocrine therapy for patients with HR-positive HER2-negative advanced breast cancer after CDK4/6 inhibitors treatment: clinical findings and exploratory circulating tumor cell and ctDNA biomarker analyses of a multicenter, phase 2 study (SYSUCC-020 trial).
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This multicenter, Simon two-stage phase 2 clinical trial evaluated the efficacy, safety and biomarker correlates of combining the HDAC inhibitor tucidinostat with metronomic capecitabine and endocrine therapy in women with hormone-receptor–positive, HER2-negative advanced breast cancer that had progressed on prior CDK4/6 inhibitors. Sixty-six patients received tucidinostat plus metronomic capecitabine with either an aromatase inhibitor (Cohort 1) or fulvestrant (Cohort 2) and were followed for a median of 13.88 months. The objective response rate was 25.8 % (17 partial responses), and median progression-free survival was 5.39 months overall (6.93 months in Cohort 1 and 3.98 months in Cohort 2); 93.9 % experienced at least one adverse event. Exploratory analyses showed longer PFS in patients with TP53 wild-type tumors (7.64 vs 3.55 months) and CTC-negative status (7.59 vs 3.78 months), supporting the regimen’s clinical activity and manageable safety profile after CDK4/6 inhibitor failure.
10.1038/s41392-026-02632-5
A phase 1 study of ASTX727 plus talazoparib in patients with triple-negative or hormone resistant/HER2-negative metastatic breast cancer.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This phase 1, open-label, dose-escalation trial used a classical 3 + 3 design to evaluate the safety, tolerability and preliminary activity of the oral DNA methyltransferase inhibitor ASTX727 in combination with the PARP inhibitor talazoparib in 34 patients with previously treated, BRCA-wild-type triple-negative or hormone-resistant/HER2-negative metastatic breast cancer. Safety analysis in all treated patients showed frequent myelosuppression, with grade ≥3 neutropenia in 42 % and grade 3 anemia or thrombocytopenia in 13 %, and neutropenia was the only dose-limiting toxicity. Among 29 patients evaluable for efficacy, no objective responses were recorded, while six patients (≈21 %) achieved stable disease lasting more than four months; pharmacodynamic assessments revealed LINE-1 demethylation of ~2–10 % and 1–5 % changes in immune-specific CpG methylation by day 15, without clear dose dependence. The investigators concluded that ASTX727 plus talazoparib produces significant hematologic toxicity, limited epigenetic modulation, and negligible objective antitumor activity in this heavily pretreated population, though some prolonged disease stabilization was observed.
10.1002/cncr.70407
Genomic Determinants of Response to Alpelisib Plus Fulvestrant in the SOLAR-1 Trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The study aimed to analyze genomic determinants of response to alpelisib plus fulvestrant in patients with PIK3CA-altered, HR+, HER2- advanced breast cancer (ABC) from the SOLAR-1 trial, using a retrospective analysis of tissue-based next-generation sequencing data from 398 patients. Key findings showed that PIK3CA-altered patients receiving alpelisib plus fulvestrant had a median progression-free survival (mPFS) of 11.01 months versus 5.55 months for placebo plus fulvestrant (P=0.0004), with specific subgroups (low tumor mutational burden, FGFR1/FGFR2 alterations) showing greater benefit (18.5 vs. 3.22 months; HR 0.38). The study concluded that alpelisib plus fulvestrant provides clinical benefit across various genomic alterations, and machine learning models identified factors like PTEN/TP53 mutations as deleterious for PFS.
10.1016/j.annonc.2026.04.003
Apr 06 – Apr 13, 2026
Patient-reported outcomes and qualitative interviews in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: results from the phase III EMBER-3 trial.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This study reports exploratory patient-reported outcomes (PROs) and qualitative interviews from the phase III EMBER-3 trial in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer, comparing imlunestrant with standard endocrine therapy (fulvestrant or exemestane) and imlunestrant plus abemaciclib versus imlunestrant monotherapy. PRO instruments included EORTC QLQ-C30 and PRO-CTCAE items for diarrhea and injection site reactions, analyzed via longitudinal mixed models (10-point threshold for clinical meaningfulness), descriptive summaries, and directed content analysis of interviews. Global health status/quality of life and function were generally maintained across treatment arms, with treatment differences favoring imlunestrant versus standard of care in the ESR1-mutated population and fewer deterioration events in imlunestrant arms; 72.3% of fulvestrant-treated patients reported injection site reactions and diarrhea frequency was higher in the imlunestrant-abemaciclib combination arm. The authors conclude that PRO findings complement efficacy and safety data and support a favorable risk-benefit profile of imlunestrant, alone or with abemaciclib.
10.1016/j.esmoop.2026.106945
Efficacy of scalp cooling system versus chemical cooling cap in preventing chemotherapy-induced alopecia in breast cancer (COHAIR Study): a prospective randomized trial.
BREAST · Q1 JOURNAL - RANK #4/140
This study aimed to compare the efficacy of a scalp cooling system and a chemical cooling cap in preventing chemotherapy-induced alopecia (CIA) among breast cancer patients in a prospective, randomized clinical trial. A total of 152 patients with early breast cancer were randomized, and 117 completed the study after receiving four cycles of anthracycline followed by four cycles of taxane. The scalp cooling system demonstrated a higher early efficacy in hair preservation rates during anthracycline treatment (74.5% vs. 71.2% for chemical cooling cap), while the chemical cooling cap group reported lower anxiety, better quality of life (QoL) outcomes, and comparable tolerability and disease-free survival (DFS) between groups. These results suggest that both cooling methods are effective for CIA management, with specific benefits in hair preservation for scalp cooling and psychological outcomes for chemical cooling caps.
10.1016/j.breast.2026.104784
Long-term prognostic value of ctDNA in early breast cancer: insights from the neoadjuvant ABCSG-34 Trial.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
This study aimed to evaluate the long-term prognostic significance of circulating tumor DNA (ctDNA) dynamics in early breast cancer, leveraging follow-up data from the ABCSG-34 phase II trial. The trial randomized 400 patients to chemotherapy or endocrine therapy, with or without the MUC1 vaccine, and utilized tumor-informed SiMSen-Seq assays to track ctDNA over time. Among 145 patients with available ctDNA data, long-term data from 109 patients showed that baseline ctDNA positivity was associated with inferior overall survival (HR 2.12, p = 0.043), while ctDNA clearance during therapy correlated with improved outcomes albeit without statistical significance. The findings highlight baseline ctDNA as a potential prognostic marker and suggest its utility in monitoring minimal residual disease and treatment efficacy, though further validation is necessary in larger trials.
10.1038/s41523-026-00934-z
Efficacy and Genomic Analysis of HER2-Mutant Metastatic Triple-Negative Breast Cancer Treated with Neratinib Alone or with Trastuzumab in the SUMMIT Basket Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This prospective phase II basket clinical trial evaluated neratinib alone versus neratinib plus trastuzumab in HER2-mutant metastatic triple-negative breast cancer, enrolling 27 patients between July 2014 and September 2021. The primary endpoint was investigator-assessed objective response rate at first post-baseline tumor assessment, with confirmed ORRs reported as 40.0% (95%CI 12.2-73.8) for neratinib and 35.3% (95%CI 14.2-61.7) for the combination; clinical benefit rates and median progression-free survival were also assessed. Serial ctDNA analysis showed decreased HER2 variant allele frequencies with clinical response and emergence of new mutations with progression. The study concluded that neratinib-based combinations, especially neratinib plus trastuzumab, offer prolonged responses and represent a novel treatment approach for HER2-mutant metastatic TNBC.
10.1158/1078-0432.CCR-25-4135
Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This randomised, open-label, international phase III trial evaluated datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy in 644 patients with previously untreated, locally recurrent inoperable or metastatic triple-negative breast cancer ineligible for immunotherapy. Participants were assigned 1:1 to Dato-DXd 6 mg/kg intravenously every three weeks or standard chemotherapy, with dual primary endpoints of progression-free survival (PFS) and overall survival (OS) assessed in the intention-to-treat population by blinded independent central review. Median PFS was 10.8 months with Dato-DXd versus 5.6 months with chemotherapy (HR 0.57, 99% CI 0.44-0.73, P < 0.0001), and median OS was 23.7 months versus 18.7 months, respectively (HR 0.79, 95.01% CI 0.64-0.98, P = 0.029). Grade ≥3 treatment-related adverse events occurred in 33% of Dato-DXd and 29% of chemotherapy recipients, with no treatment-related deaths, leading the authors to conclude that Dato-DXd provides significant efficacy benefits with acceptable safety for this patient population.
10.1016/j.annonc.2026.03.008
Mar 30 – Apr 06, 2026
The benefit of adjuvant pertuzumab and trastuzumab according to estrogen receptor and HER2 expression: a Sub-analysis of the APHINITY trial.
JNCI-J NATL CANCER I · Q1 JOURNAL - RANK #44/326
This study is a sub-analysis of the APHINITY trial, a prospective randomized double-blind phase III clinical trial, designed to evaluate the benefit of adding pertuzumab to trastuzumab and chemotherapy in HER2-positive early breast cancer patients, based on estrogen receptor (ER) and HER2 levels. Analyses of invasive disease-free survival (IDFS) showed that all patient subgroups benefited from pertuzumab, with the HER2 FISH-low/ER-positive subgroup demonstrating the greatest benefit (HR 0.70, 95% CI 0.51-0.95), and the HER2 FISH-high/ER-negative subgroup showing minimal improvement (HR 0.85, 95% CI 0.59-1.25). The study excluded tumors with HER2 FISH ratio <2 and adjusted analyses for factors such as treatment arm, chemotherapy regimen, and nodal status or protocol version. Conclusions suggest a need for validation of these findings through prospective biomarker-guided approaches to optimize patient outcomes.
10.1093/jnci/djag095