✦ Cancer Clinical Trials

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Jul 20 – Jul 27, 2026

Eribulin versus taxane as first-line chemotherapy combined with dual HER2 blockade in patients with HER2-positive locally advanced or metastatic breast cancer: final survival outcomes of the JBCRG-M06/EMERALD study.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
The phase III JBCRG-M06/EMERALD study compared eribulin and taxane combined with dual HER2 blockade as first-line chemotherapy for HER2-positive locally advanced or metastatic breast cancer (LABC/MBC). A total of patients were randomized 1:1 and primary outcomes included progression-free survival (PFS) and overall survival (OS). Median OS was 78.5 months for eribulin and not reached for taxane (HR 1.25, 95% CI 0.92-1.71, P=0.19), with 60-month OS rates of 59.7% and 65.2% respectively. The study concluded that both regimens provided over 6-year median survival with no significant differences, while ctDNA PIK3CAm+ mutations were prognostic of shorter survival and ctDNA HER2 amp+ was linked to longer survival.
10.1016/j.esmoop.2026.108325

Associations Between Cardiac Radiation Dose-Volume Metrics and Health-Related Quality of Life for Patients With Breast Cancer on the RadComp Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This study analyzes data from the RadComp pragmatic randomized clinical trial comparing proton versus photon radiotherapy in breast cancer patients. The primary objective was to evaluate associations between cardiac radiation dose-volume metrics and health-related quality of life (HRQOL) outcomes. Key findings include significantly lower mean heart dose with protons (0.89 Gy vs 2.99 Gy, p<0.001) but no significant associations between any dose-volume histogram parameters and cardiac-related HRQOL measures over 6 months post-treatment. The authors conclude that proton therapy confers lower cardiac doses but that no early HRQOL differences were detected, with grade ≥3 toxicity remaining uncommon (≤5.5%).
10.1016/j.ijrobp.2026.06.3055

The WinPro trial: window-of-opportunity study of endocrine therapy with micronised progesterone in ER-positive breast cancer.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
The WinPro trial is a randomized, multi-centre, prospective, phase 2 window-of-opportunity study of micronised progesterone (MP) in post-menopausal women with ER+, PR+, HER2- breast cancer. The methodology involved random assignment to letrozole, letrozole plus MP, or tamoxifen plus MP for 14 days preoperatively with Ki67 suppression as the primary endpoint. Among 189 evaluable patients, Ki67 suppression was similar in the letrozole (88.2%) versus letrozole+MP (89.2%) groups (p=0.39), but was lower in the tamoxifen+MP arm (61.5%), with fewer hot flushes in the letrozole+MP group (13.3%). The study concludes that while MP combined with letrozole did not significantly enhance Ki67 suppression compared to letrozole alone, the combination was associated with reduced vasomotor side effects and warrants further investigation.
10.1038/s41523-026-01008-w

The Role of Locoregional Treatment in Non-Progressive De Novo Metastatic Breast Cancer under Systemic Treatment: A Randomized Controlled Trial (LTMBC).
ANN SURG ONCOL · Q1 JOURNAL - RANK #39/312
This randomized controlled trial examined the role of locoregional treatment (LRT) compared to systemic treatment (ST) in patients with non-progressive de novo metastatic breast cancer (DnMBC) under systemic therapy. A total of 250 patients were randomized to an LRT group (n = 158) and an ST-only group (n = 92), with follow-ups every three months over five years. The study found no significant differences in overall survival (OS) between the LRT (median OS: 53 months) and ST (median OS: 55 months) groups (adjusted HR: 0.08; 95% CI: 0.9-1.3; p = 0.35). However, patients with HER2+ status (HR: 1.86; p = 0.005) and lung metastases (HR: 1.5; p = 0.03) exhibited an increased risk of death, concluding that LRT did not improve long-term OS outcomes in DnMBC cases under systemic therapies.
10.1245/s10434-026-20187-1

Jul 13 – Jul 20, 2026

Tumor infiltrating lymphocytes as a predictor of adjuvant avelumab efficacy in patients with high-risk triple negative breast cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This study is a prospective, randomized phase III clinical trial (A-BRAVE) evaluating avelumab adjuvant immunotherapy versus observation in 466 patients with high-risk early triple-negative breast cancer. The primary objective was to investigate the prognostic and predictive value of tumor-infiltrating lymphocytes (TILs) for treatment outcomes. Higher baseline TILs (>=30%) significantly predicted avelumab benefit, with 3-year distant disease-free survival rates of 92.0% vs. 58.7% (HR 0.20) in high-TIL patients versus 70.4% vs. 70.1% (HR 0.92) in low-TIL patients (interaction p=0.019). The authors conclude TILs may guide adjuvant immunotherapy strategies pending validation.
10.1158/1078-0432.CCR-26-0975

Recurrence Score® gene group components and outcomes in the RxPONDER trial (SWOG S1007).
JNCI-J NATL CANCER I · Q1 JOURNAL - RANK #44/326
The RxPONDER trial assessed the impact of Recurrence Score® gene components on outcomes in 3,102 patients with HR+/HER2- breast cancer (RS ≤ 25, 1-3 positive nodes), randomized to endocrine therapy ± chemotherapy. Subgroup analyses revealed significant ethnic variations in proliferation (e.g., NHB vs. NHW, p=0.003) and other gene pathways (e.g., Asian women had higher HER2 scores, p=0.006), with no statistically significant IDFS differences in NHB women (HR 1.41, 95% CI 0.98-2.03) but improved IDFS in Asian women (HR 0.63, 95% CI 0.43-0.91). Multivariable Cox modeling underscored disparities in pathway contributions to prognosis. The study advocates for greater focus on pathway-specific biology beyond composite RS to address outcome disparities and enhance precision in risk stratification.
10.1093/jnci/djag221

Avutometinib, Abemaciclib, and Fulvestrant in Patients with HR+/HER2- Metastatic Breast Cancer Previously Treated with CDK4/6 Inhibitor: A Single-Arm Phase I Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase I single-arm trial evaluated the safety and efficacy of avutometinib, abemaciclib, and fulvestrant in 16 patients with HR+/HER2- metastatic breast cancer previously treated with CDK4/6 inhibitors. The primary endpoint was maximum tolerated dose (MTD), with secondary endpoints including safety, pharmacokinetics, overall response rate (ORR), clinical benefit rate (CBR), and progression-free survival (PFS). The MTD and recommended phase 2 dose were abemaciclib 100 mg BID, avutometinib 3.2 mg BIW, and fulvestrant 500 mg IM q28d, with an ORR of 13% (2/15), 24-week CBR of 40% (6/15), and median PFS of 3.6 months (95% CI: 2.1-not reached). The regimen was well-tolerated with no grade 4-5 TRAEs and showed preliminary clinical activity, prompting an ongoing phase II trial.
10.1158/1078-0432.CCR-26-0721

Switching to camizestrant at ESR1 mutation emergence before disease progression during first-line treatment of hormone receptor-positive advanced breast cancer (SERENA-6): extended analysis of a double-blind, placebo-controlled, randomised, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This study evaluated SERENA-6, a double-blind, placebo-controlled, randomized phase 3 trial, investigating the impact of switching to camizestrant with continued CDK4/6 inhibitor versus continuing aromatase inhibitor plus CDK4/6 inhibitor upon ESR1 mutation emergence in hormone receptor-positive advanced breast cancer. With a sample size of 315 patients and a median follow-up of 23.5 months, the switch to camizestrant improved median progression-free survival (16.8 vs. 9.2 months; HR 0.45, p<0.0001) and second progression-free survival (25.7 vs. 19.1 months; HR 0.63, p=0.0037). Grade 3-4 adverse events, including neutropenia and decreased neutrophil count, were observed, with three treatment-related deaths reported. The findings support the proposed strategy of switching at ESR1 mutation emergence to delay progression, thus optimizing first-line therapeutic outcomes in advanced breast cancer.
10.1016/S1470-2045(26)00287-1

Jul 06 – Jul 13, 2026

Lactobacillus reuteri lozenges and chemotherapy-induced oral mucositis in breast cancer outpatients: an exploratory randomized controlled trial.
SCI REP-UK · Q1 JOURNAL - RANK #25/135
This exploratory, single-center, open-label, randomized controlled trial examined the effect of Lactobacillus reuteri lozenges on chemotherapy-induced oral mucositis in breast cancer outpatients receiving anthracycline- or taxane-based chemotherapy. Sixty-seven patients were randomized to receive L. reuteri lozenges twice daily for 12 weeks or no intervention, with 61 analyzed. The primary outcome of Grade ≥2 oral mucositis showed no significant difference in cycles 1-2, but lower incidence in the L. reuteri group in cycles 3 (22.6% vs. 50.0%) and 4 (19.4% vs. 43.3%); a mixed-effects model found no significant time-by-intervention effect. The authors conclude that L. reuteri lozenges may be associated with reduced oral mucositis in later cycles, with no intervention-related adverse events.
10.1038/s41598-026-61752-8

Neoadjuvant Chemotherapy with Trastuzumab with or without Concurrent Radiotherapy in HER2-Positive Locally Advanced Inoperable Breast Cancer- A Phase 2 Randomized Controlled Trial (NEOTRAC STUDY).
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This phase 2 randomized controlled trial (NEOTRAC) evaluated neoadjuvant concurrent chemoradiotherapy (NACCRT) with trastuzumab versus standard neoadjuvant chemotherapy (NACT) in 118 patients with HER2-positive, inoperable locally advanced breast cancer (stage III). Patients were randomized 1:1 to Arm A (NACT+trastuzumab) or Arm B (NACCRT+trastuzumab), both receiving anthracycline/taxane-based chemotherapy with trastuzumab; Arm B received concurrent radiotherapy (46 Gy) during paclitaxel. The primary endpoint pCR was 46.6% (Arm A) vs. 50.9% (Arm B) (P=0.64), with no significant differences in 3-year event-free survival (79.8% vs. 76.8%) or overall survival (88.7% vs. 87.4%). The study concluded NACCRT with trastuzumab is feasible, safe, and significantly shortens treatment duration without compromising survival, warranting further evaluation.
10.1016/j.ijrobp.2026.06.3086

Addition of angiogenesis inhibitors to CDK4/6 inhibitors and fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer.
CHINESE MED J-PEKING · Q1 JOURNAL - RANK #23/332
This prospective phase Ib/II trial evaluated the feasibility and efficacy of combining the angiogenesis-targeting tyrosine kinase inhibitor famitinib with dalpiciclib and fulvestrant in HR+/HER2- advanced breast cancer. A standard 3+3 dose-escalation design identified 10 mg famitinib plus 100 mg dalpiciclib daily, along with fulvestrant, as the recommended phase II dose. Among 28 phase II participants, the confirmed objective response rate was 51.9% (95% CI: 32.0%-71.3%) and the median progression-free survival reached 15.7 (95% CI: 7.3-25.4) months. Although the combination showed promising response rates, overlapping hematologic toxicities led to early termination of enrollment.
10.1097/CM9.0000000000004191

Incidence and Predictors of Fat Necrosis After Single-Fraction Stereotactic Partial Breast Irradiation for Early-Stage Breast Cancer: Results From a Phase II Clinical Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This study evaluated predictive factors for fat necrosis (FN) after stereotactic partial breast irradiation (S-PBI) in early-stage breast cancer through a prospective phase II clinical trial involving 148 patients treated with a 17.5 Gy single dose using GammaPod™ technology. FN was clinically and radiologically assessed with a median follow-up of 29.9 months. FN occurred in 12.1% of patients, with symptomatic FN in 4.1%, and the cumulative incidence increased over time. The study concluded S-PBI was well-tolerated, and advanced age (≥60) and higher dosimetric volumes (V19.3 ≥5 cc) were significant risk predictors for FN, with further statistical analyses affirming these findings.
10.1016/j.ijrobp.2026.06.3089

Olaparib in HR-deficient, metastatic triple-negative breast and platinum-sensitive relapsed ovarian cancers without germline mutations in BRCA1/2: phase 2 EMBRACE trial.
BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This single-arm phase 2 trial evaluated olaparib 300 mg orally twice daily in 22 patients with platinum-sensitive relapsed high-grade serous ovarian cancer (HGSOC) and metastatic triple-negative breast cancer (mTNBC) harboring non-germline BRCA homologous recombination deficiency (HRD). Tumor methylation (BRCA1/RAD51C) and non-BRCA HR gene mutations were analyzed with high-resolution melting PCR and targeted sequencing, with promoter methylation detected in 8/15 HGSOC and 5/7 TNBC. The 6-month objective tumor response rate (OTRR) was 40% in HGSOC (6/15) and 0% in mTNBC (0/7), while 6-month/12-month progression-free survival (PFS) rates were 53%/25% for HGSOC and 17%/0% for mTNBC. Olaparib demonstrated encouraging activity in HGSOC beyond germline BRCA1/2 mutations, but showed limited efficacy in pre-treated mTNBC.
10.1038/s41416-026-03535-6

Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This multicenter, single-arm, phase II trial prospectively assessed trastuzumab-pkrb (8 mg/kg loading, then 6 mg/kg Q3W) plus the PI3K/mTOR inhibitor gedatolisib (180 mg IV on days 1, 8, 15 of each 21-day cycle) in 44 patients with HER2-positive metastatic breast cancer harboring PI3K-pathway alterations who had progressed after ≥2 prior HER2-directed therapies. The primary objective was objective response rate (ORR); secondary endpoints included disease control, progression-free survival (PFS), overall survival (OS), safety, and circulating tumor-DNA dynamics. ORR reached 43.2 % (95 % CI 28.3–59.0) with two complete and 17 partial responses; disease control rate was 86.4 %, median PFS 6.01 months (95 % CI 5.03–7.69), and median OS 24.74 months after 32.05 months follow-up. Toxicities were mainly oral mucositis (90.9 %, 15.9 % grade ≥3) and hyperglycemia (25.0 %, 2.3 % grade 3), leading investigators to conclude the dual HER2/PI3K strategy shows clinically meaningful activity and manageable safety in heavily pretreated patients.
10.1016/j.esmoop.2026.107706

TRADE: tolerability of adjuvant abemaciclib at 6 months after initial dose escalation in patients with early-stage HR-positive/HER2-negative breast cancer.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
The TRADE trial is a prospective, single-arm, phase II study evaluating the tolerability of adjuvant abemaciclib with dose escalation in 89 patients with early-stage HR-positive/HER2-negative breast cancer. Patients started at 50 mg b.i.d., escalated to 100 mg b.i.d., and then to 150 mg b.i.d. over 4 weeks, with outcomes assessed at 24 weeks. At 24 weeks, 82.0% of patients remained on treatment, with 64.4% maintaining the target dose of 150 mg b.i.d., while 32.6% required dose reductions and 18.0% discontinued therapy. The study concludes that early dose escalation improves tolerability and persistence, with no significant decline in quality of life, supporting this strategy for optimizing adjuvant abemaciclib therapy.
10.1016/j.esmoop.2026.108247

Jun 29 – Jul 06, 2026

Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicentre, open-label, randomised, controlled phase 3 trial in China compared trastuzumab rezetecan (4.8 mg/kg IV q3w; temporary 6.4 mg/kg amendment; primary evaluation at 4.8 mg/kg) versus pyrotinib 400 mg daily plus capecitabine 1000 mg/m2 twice daily days 1–14 q21d in 287 women with HER2-positive unresectable/metastatic breast cancer after trastuzumab and taxane. The primary endpoint was BICR-assessed progression-free survival (mITT population); after median follow-up 15.0 vs 13.9 months, 124 PFS events occurred (26% vs 60%), with median PFS 30.6 months (95% CI 16.8–NR) vs 8.3 months (6.9–11.0), HR 0.22 (0.15–0.34), p<0.0001; 12-month PFS was 84.7% vs 35.5%. Grade ≥3 AEs were more frequent with trastuzumab rezetecan (neutrophils 54% vs 9%, WBC 20% vs 3%, platelets 11% vs 1%); ILD occurred in 3%; treatment-related SAEs 13% vs 12%; two deaths (one unrelated in TRZ arm, one related in control). Trastuzumab rezetecan substantially improved PFS with a distinct safety profile, supporting it as a potential new option.
10.1016/S1470-2045(26)00193-2

Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial.
JAMA SURG · Q1 JOURNAL - RANK #1/312TOP-TIER
The NRG Oncology/NSABP B-35 randomized clinical trial investigated the impact of lumpectomy margin width on ipsilateral breast tumor recurrence (IBTR) in postmenopausal women with hormone receptor-positive ductal carcinoma in situ (DCIS). This phase 3, double-blind trial randomized 3104 patients to adjuvant anastrozole or tamoxifen after lumpectomy and whole-breast irradiation, with margin width analyzed as <1 mm vs ≥1 mm and <2 mm vs ≥2 mm. IBTR occurred in 3.3% of patients (90/2707), with 10-year cumulative incidence of 5.6% for margins <1 mm vs 4.0% for ≥1 mm (P=0.04); margin width was not a significant predictor in adjusted models (HR 1.33, 95% CI 0.86-2.06 for 2-mm threshold). The study suggests reconsidering reexcision for margins <1-2 mm in selected patients, as absolute IBTR rates were small between groups.
10.1001/jamasurg.2026.2340

Effects of dexmedetomidine nasal spray on perioperative anxiety and quality of postoperative recovery in patients undergoing modified radical mastectomy for breast cancer.
FRONT MED-LAUSANNE · Q1 JOURNAL - RANK #61/332
This prospective randomized clinical trial evaluated the effects of preoperative intranasal dexmedetomidine spray on perioperative anxiety and postoperative recovery in 90 breast cancer patients undergoing modified radical mastectomy. Patients were randomly assigned to receive either dexmedetomidine (n=45) or saline (n=45), with primary outcomes measured by the Perioperative Anxiety Scale-7 (PAS-7) and secondary outcomes including Quality of Recovery-15 (QoR-15) scores, insomnia scales, and perioperative vital signs. The dexmedetomidine group showed significantly lower PAS-7 scores (9.71 ± 2.07 vs. 12.44 ± 1.98, p < 0.001) and higher QoR-15 scores at 24h (120.11 ± 6.90 vs. 111.27 ± 7.14, p < 0.001) and 48h (127.04 ± 6.39 vs. 123.20 ± 6.37, p = 0.005) postoperatively, with prolonged emergence time (8.36 ± 2.79 vs. 6.36 ± 2.83, p = 0.001). The study concluded that intranasal dexmedetomidine effectively reduced perioperative anxiety and improved early postoperative recovery without significant adverse hemodynamic effects, despite longer emergence times.
10.3389/fmed.2026.1848029

Targeting homologous recombination deficiency with intensified chemotherapy versus standard chemotherapy followed by olaparib in stage III breast cancer (SUBITO): an open-label, randomised, controlled, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This open-label, randomized, controlled, phase 3 SUBITO trial evaluated intensified alkylating chemotherapy (IACT) versus standard anthracycline-based chemotherapy plus carboplatin-paclitaxel followed by oral olaparib in stage III, HER2-negative, HRD breast cancer. A total of 174 newly diagnosed patients aged 18-66 years, without distant metastases, were randomized (1:1) at eight hospitals and two cancer centers. With a median follow-up of 41 months, the 4-year overall survival was 77·0% (95% CI 67·7-87·7) in the IACT group and 76·4% (66·9-87·4) in the olaparib group (HR 1·11 [95% CI 0·57-2·17]; p=0·37). The findings suggest that IACT provides no survival advantage over a carboplatin-paclitaxel regimen plus olaparib, as both approaches demonstrated similar efficacy.
10.1016/S1470-2045(26)00131-2

Albumin-Bound Paclitaxel (SYHX2011) in Patients with Advanced Breast Cancer: A Multicenter, Randomized, Double-Blind, Phase III Study.
CANCER COMMUN · Q1 JOURNAL - RANK #12/326TOP-TIER
This multicenter, randomized, double-blind phase III trial compared the novel albumin-bound paclitaxel SYHX2011 with standard albumin-bound paclitaxel (PAB) in 459 patients with unresectable locally advanced or metastatic breast cancer who received 260 mg/m² IV every three weeks. The primary endpoint, objective response rate assessed by an independent review committee, was 35.8 % for SYHX2011 versus 25.8 % for PAB (rate ratio = 1.38, 95 % CI 1.04-1.84; one-sided p = 0.012), meeting non-inferiority and demonstrating superiority. Rash occurred less often with SYHX2011 during all cycles (16.2 % vs 42.6 %), while grade ≥3 treatment-related adverse events were comparable (48.7 % vs 43.9 %). Researchers concluded that SYHX2011 offers greater efficacy, reduced rash, and faster reconstitution time (2 min vs 11 min), providing an effective, convenient option for advanced breast cancer.
10.34133/cancomm.0037

Tailoring radiotherapy in cT1-2N1 breast cancer to nodal response on primary chemotherapy (RAPCHEM: BOOG 2010-03): 10-year follow-up results of a Dutch, prospective, registry study.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This prospective registry study (RAPCHEM, BOOG 2010-03) evaluated tailored postoperative radiotherapy in cT1-2N1 breast cancer patients after primary chemotherapy, with 838 patients followed for 10 years. Patients were assigned to low-, intermediate-, or high-risk groups based on nodal response, receiving corresponding radiotherapy guidelines (e.g., low-risk: whole breast RT after lumpectomy, no RT after mastectomy; high-risk: whole breast/chest wall RT plus regional nodal RT). The 10-year locoregional recurrence rate was 2.9% (95% CI 1.9-4.2) overall, with no significant differences between groups; 10-year recurrence-free interval was 79.2% (76.2-81.8) and overall survival 83.0% (80.3-85.4). The authors conclude that tailoring radiotherapy to nodal response yields low locoregional recurrence and may reduce radiotherapy-related morbidity.
10.1016/S1470-2045(26)00216-0

Internal mammary chain and medial supraclavicular lymph node irradiation in stage I-III breast cancer (EORTC trial 22922/10925): an unplanned subset analysis of 20-year outcomes in patients with node-negative breast cancer.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This unplanned subgroup analysis of the randomized, open-label, phase III EORTC 22922/10925 trial assessed whether adding internal mammary and medial-supraclavicular (IM-MS) nodal irradiation benefits women with pN0 stage I-III breast cancer. Between 1996 and 2004, 1,778 node-negative patients from 46 centres were randomly assigned to receive IM-MS irradiation (50 Gy in 25 fractions) or no IM-MS; median follow-up was 22.2 years and outcomes were analysed by intention-to-treat. Twenty-year overall survival was similar (69.0% vs 68.4%; HR 0.98, p = 0.77), but breast-cancer mortality was reduced (10.0% vs 14.2%; HR 0.70, p = 0.010) while non-breast-cancer mortality rose (20.9% vs 17.4%; HR 1.24, p = 0.048); lung fibrosis occurred in 6.4% vs 2.1% and cardiac fibrosis in 3.4% vs 2.8% of left-sided cases. IM-MS irradiation lowers breast-cancer deaths but yields no overall survival gain owing to higher late non-cancer mortality, underscoring the need for modern techniques and very long follow-up.
10.1016/S1470-2045(26)00233-0

Jun 22 – Jun 29, 2026

Dose-dense adjuvant chemotherapy in HER2-low breast cancer: An exploratory analysis of the GIM2 trial.
BREAST · Q1 JOURNAL - RANK #4/140
This exploratory analysis of the GIM2 trial aimed to assess the efficacy of dose-dense adjuvant chemotherapy in HER2-negative breast cancer patients, stratified by HER2 immunohistochemistry (IHC) score. In this prospective, randomized study, 1243 node-positive early breast cancer patients received either dose-dense or standard schedule anthracycline- and taxane-based chemotherapy, and outcomes were analyzed over a median follow-up of 14.9 years. No interaction was found between HER2 subgroup and treatment effect on invasive disease-free survival (iDFS) or overall survival (OS) (p for interaction = 0.42 and 0.34, respectively); adjusted hazard ratios for iDFS and OS for HER2-zero and HER2-low groups ranged from 0.55 to 0.84. The principal conclusion is that dose-dense chemotherapy benefited patients regardless of HER2 status.
10.1016/j.breast.2026.104848

Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events.
NPJ BREAST CANCER · Q1 JOURNAL - RANK #42/326
The primary objective was to evaluate outcomes in the phase 3 KEYNOTE-355 randomized trial after stopping chemotherapy before pembrolizumab and to characterize immune-mediated adverse events in advanced triple-negative breast cancer (TNBC) with PD-L1 CPS ≥ 10. The methodology involved comparing progression-free survival (PFS) and overall survival (OS) among patients discontinuing chemotherapy yet continuing pembrolizumab, with analysis of immune-mediated AEs and their management. Chemotherapy discontinuation before pembrolizumab resulted in similar median PFS and OS to the overall cohort; patients with immune-mediated AEs showed numerical improvement in efficacy. The study concludes that pembrolizumab plus chemotherapy remains an effective standard-of-care in this population, with manageable immune-mediated AEs and sustained efficacy even after chemotherapy discontinuation.
10.1038/s41523-026-00971-8

Cannabis Oil and Exploratory Gut-Immune Signatures During Breast Cancer Chemotherapy: A Randomized Pilot Trial.
BIOMEDICINES · Q1 JOURNAL - RANK #88/352
This double-blind, placebo-controlled pilot trial investigated cannabis oil administration in 10 women undergoing chemotherapy for breast cancer, with the primary objective of assessing the feasibility of monitoring short-chain fatty acids (SCFAs) and systemic cytokines as exploratory biomarkers. Participants were randomized to receive cannabis oil (n=6) or placebo (n=4) for 12 weeks, with dietary stability confirmed via food frequency questionnaires. SCFA and cytokine analyses showed non-significant (all p>0.05) numeric trends favoring reduced proteolytic metabolites (iso-butyric acid) and attenuated pro-inflammatory cytokines (IL-6, IL-8, IL-1β, TNF-α) in the cannabis group. Although limited by a small sample size, these findings support further investigation of cannabis oil’s impact on gut microbial and immune responses in larger trials.
10.3390/biomedicines14061367

Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab for Stage II to III, ERBB2-Positive Breast Cancer: A Secondary Analysis of the DAPHNe Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This secondary analysis of the prospective, single-arm phase 2 DAPHNe trial evaluated 5-year outcomes and ctDNA dynamics in 98 patients with stage II-III ERBB2-positive breast cancer treated with neoadjuvant paclitaxel, trastuzumab, and pertuzumab (THP). With a median follow-up of 5.2 years, the 5-year event-free survival was 99% (95% CI, 97%-100%), recurrence-free interval 98% (95% CI, 93%-100%), distant recurrence-free interval 100% (95% CI, 100%-100%), and overall survival 99% (95% CI, 97%-100%). ctDNA clearance occurred in 96.1% of patients post-neoadjuvant therapy, with only 3.9% remaining ctDNA-positive preoperatively. The study demonstrates excellent long-term outcomes with THP and supports ctDNA-guided de-escalation strategies in ERBB2-positive breast cancer.
10.1001/jamaoncol.2026.2023

Quality of life with palbociclib plus tamoxifen in hormone receptor-positive, HER2-negative advanced breast cancer: results from PATHWAY, an Asian international, double-blind, randomized phase 3 trial.
BREAST CANCER-TOKYO · Q1 JOURNAL - RANK #26/140
The PATHWAY trial was a double-blind, randomized phase 3 clinical trial studying the effects of combining palbociclib and tamoxifen versus placebo and tamoxifen on quality of life (QoL) in Asian women with HR+/HER2- advanced breast cancer (ABC). QoL was assessed at multiple points using EORTC QLQ-C30 and QLQ-BR23 questionnaires, analyzing changes in scores and time to deterioration (TTD) in the pain subscale. No significant or clinically meaningful differences were found in overall global QoL measures between arms, but TTD in the pain subscale was longer in the palbociclib-tamoxifen group (32.5 months vs. 21.2 months; HR=0.729). The study concluded that the combination delayed QoL deterioration while reducing disease progression risk, with registration listed on ClinicalTrials.gov (NCT03423199).
10.1007/s12282-026-01865-0

Transcranial direct current stimulation for perioperative depression in breast cancer surgery: a randomized controlled trial.
TRANSL PSYCHIAT · Q1 JOURNAL - RANK #21/288
This randomized controlled trial investigated the efficacy of transcranial direct current stimulation (tDCS) in alleviating perioperative depression in patients undergoing breast cancer surgery, with 64 participants randomly assigned to active or sham tDCS groups. Interventions were delivered daily from preoperative day to the fifth postoperative day, with assessments at baseline, day 5, and 1 month post-surgery for depression (HAMD-17, BDI-13), sleep quality (PSQI), pain scores (NRS), and adverse reactions. The active tDCS group showed significantly lower HAMD scores (4.67 vs. 6.37, P=0.01), NRS scores (P<0.001), and PSQI scores (3.57 vs. 4.87, P=0.016) at day 5, as well as fewer cases of postoperative nausea and vomiting (P=0.018). tDCS accelerated depression relief during acute recovery and improved short-term postoperative outcomes.
10.1038/s41398-026-04209-w

Primary results from EL1SSAR, a prospective phase IIIb study of first-line atezolizumab plus nab-paclitaxel therapy for patients with PD-L1-positive advanced triple-negative breast cancer.
BREAST · Q1 JOURNAL - RANK #4/140
The EL1SSAR study was a prospective phase IIIb single-arm clinical trial evaluating the safety and efficacy of first-line atezolizumab plus nab-paclitaxel in 182 patients with PD-L1-positive advanced triple-negative breast cancer (aTNBC). Patients received atezolizumab (840 mg, days 1&15) and nab-paclitaxel (100 mg/m², days 1,8,15) every 28 days until disease progression or unacceptable toxicity, with primary endpoints focusing on grade ≥2 immune-mediated and grade ≥3 adverse events (AEs). Key findings included grade ≥2 immune-mediated AEs in 12% (95% CI 8%-18%) and grade ≥3 AEs in 47% (95% CI 39%-54%), with median progression-free survival (PFS) of 7.4 months (95% CI 5.6-10.6) and overall survival of 27.0 months (95% CI 22.0-33.8). The study concluded that safety and efficacy were consistent with the IMpassion130 trial, supporting the regimen’s use in a broader patient population.
10.1016/j.breast.2026.104836

SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This randomized phase II trial evaluated sacituzumab govitecan (SG) with or without pembrolizumab in 104 patients with metastatic hormone receptor-positive/HER2-negative breast cancer pretreated with endocrine therapy and up to one chemotherapy regimen. Patients were randomized 1:1 and followed for a median of 15.5 months; the primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), and toxicity. SG+pembrolizumab did not significantly improve PFS over SG alone (8.4 vs 6.7 months, HR 0.76, 95% CI 0.48-1.19, p=0.12), with ORR of 28.8% vs 19.2% (p=0.36); trends toward improved PFS/OS were observed in PD-L1-positive patients. Adverse events were consistent with known profiles, and correlative analyses revealed no association between TROP2 expression and outcomes.
10.1016/j.annonc.2026.06.012

Jun 15 – Jun 22, 2026

Body mass index in postmenopausal women with estrogen receptor-positive, HER2-negative early breast cancer: An exploratory analysis of the LORELEI trial.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
LORELEI was a randomized neoadjuvant trial comparing taselisib plus letrozole versus placebo plus letrozole in 329 postmenopausal women with estrogen receptor-positive/HER2-negative early breast cancer. The study aimed to explore the impact of body mass index on objective response rate (ORR), safety, molecular features, and breast density. In the placebo group, a higher BMI was associated with a lower ORR (OR 0.90, 95% CI 0.83-0.97), whereas no association was observed in the taselisib arm (OR 1.03, 95% CI 0.96-1.11). Investigators concluded that obesity was associated with lower ORR with letrozole alone, but not in patients receiving additional taselisib.
10.1016/j.ejca.2026.116880

Limb cold therapy for preventing paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study.
WORLD J SURG ONCOL · Q1 JOURNAL - RANK #70/312
This prospective randomized controlled study evaluated the effectiveness of limb cold therapy in preventing paclitaxel-induced peripheral neuropathy (PIPN) in 200 breast cancer patients undergoing chemotherapy. Participants were randomized into a control group (n=103) receiving standard treatment and a cold therapy group (n=97) using ice gloves and socks, with outcomes assessed via CIPNAT, NCI-CTCAE, FACT/GOG-Ntx scales, neurophysiological tests, and ADL measures. The cold therapy group showed significantly reduced CIPN severity from the fourth cycle (64.95% vs. 44.66% grade 0, P=0.013), lower CIPNAT scores (124.63±59.21 vs. 147.79±77.94, P=0.019), and improved FACT/GOG-Ntx (15.48±3.61 vs. 17.12±3.57, P=0.001) and ADL scores (76.96±5.11 vs. 74.61±5.21, P=0.002). The study concluded that limb cold therapy mitigates PIPN symptoms and improves quality of life in breast cancer patients.
10.1186/s12957-026-04448-7

Impact of ultrahypofractionated adjuvant regional nodal radiotherapy on patient-reported quality of life: the HYPORT adjuvant trial (NCT03788213).
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
The HYPORT Adjuvant trial (NCT03788213) prospectively compared a one-week (26 Gy) ultrahypofractionated radiotherapy regimen to a three-week (40 Gy) moderately hypofractionated regimen, specifically investigating the interaction of regional nodal irradiation (RNI) and dose fractionation on patient-reported quality of life (QoL). Using EORTC-QLQ-C30 and FACT-B questionnaires at baseline, end of RT, and up to 18 months post-RT, linear mixed models were applied to 2173 evaluable patients, of whom 1508 (69.4%) received RNI. At 18 months, marginal means for global QoL in RNI patients were 71.75 (control) and 71.80 (experimental), with no significant interaction (coefficient -0.36, p=0.8), and arm swelling rates were 7.6% versus 5.7%. The study concluded that ultrahypofractionated RNI did not worsen QoL compared to moderately hypofractionated RT.
10.1016/j.radonc.2026.111576

Low-Cost Dual-Dye Axillary Reverse Mapping in Locally Advanced Breast Cancer After Neoadjuvant Chemotherapy: A Phase I Feasibility and Arm-Related Quality of Life Outcomes Study.
WORLD J SURG · Q1 JOURNAL - RANK #70/312
This phase I prospective study evaluated the feasibility and arm-related quality of life outcomes of low-cost dual-dye axillary reverse mapping (ARM) in 32 patients with locally advanced breast cancer (LABC) after neoadjuvant chemotherapy (NACT). Patients were assigned to standard axillary lymph node dissection (ALND; n=16) or ALND with ARM (n=16) using fluorescein sodium and methylene blue. At 12 months, the ARM group showed significantly higher LYMPH-Q Symptoms scores (p=0.039) and greater improvement from baseline (p=0.017), with significantly lower increases in arm circumference and a non-significant reduction in lymphedema incidence (p=0.600). The authors conclude that low-cost dual-dye ARM is feasible in LABC after NACT and may improve patient-reported arm symptoms without compromising operative or pathological outcomes.
10.1002/wjs.70462

Financial Toxicity of Shorter Versus Longer Partial Breast Irradiation: A Randomized Clinical Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
Within a prospective, randomized phase III trial among 778 women with early-stage breast cancer, the aim was to determine if shortened partial breast radiation reduces financial toxicity (FT) in comparison to a longer schedule. The participants were randomized to external beam partial breast irradiation across 15-22 fractions (control) or 5-13 fractions (experimental) in a multi-center trial (NCT03077841), with FT measured using the ENRICh scale at baseline, end of treatment, and follow-up. The shorter radiation course significantly lowered FT by −2.0 (95% CI −3.6 to −0.4; P=0.02) from baseline to the end of treatment compared to the longer course, though below the minimal important difference of 2.2. They conclude that a reduced radiation schedule confers a modest improvement in FT scores by the end of treatment.
10.1016/j.ijrobp.2026.05.046

Jun 08 – Jun 15, 2026

Anlotinib combined with neoadjuvant chemotherapy for HR+/HER2- breast cancer (ACNTBC): a prospective, single-arm, single-center phase II clinical study with real-world validation.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This prospective, single-arm, single-center phase II trial (NCT05558722) evaluated neoadjuvant anlotinib (12 mg qd, days 1–14, q3w; 5 cycles) combined with nab-paclitaxel (200 mg/m2 q3w), pirarubicin (50 mg/m2 q3w), and cyclophosphamide (500 mg/m2 q3w; 6 cycles) in HR+/HER2- breast cancer. The primary endpoint was total pathological complete response (tpCR), with secondary endpoints including RCB 0/I, ORR, and safety; 31 patients were enrolled. ORR was 93.5% (29/31, 95% CI 78.6–99.2); among 28 completing treatment and surgery, tpCR was 14.3% (4/28, 95% CI 4.0–32.7) and RCB 0/I was 25.0% (7/28, 95% CI 10.7–44.9). Grade 3/4 toxicities (hematologic, hypertension, proteinuria, headache) were manageable; biomarker analyses linked higher baseline VEGFR2/MVD to better efficacy, with an exploratory IPTW real-world comparison suggesting benefit over chemotherapy alone.
10.1038/s41392-026-02788-0

First-line ET plus palbociclib versus standard mono-chemotherapy in high-risk HR-positive/HER2-negative metastatic breast cancer and indication for chemotherapy: primary results from the randomized phase IV PADMA study.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
The PADMA study is a prospective, randomized, open-label, multicenter phase IV trial comparing first-line palbociclib plus endocrine therapy (ET) versus mono-chemotherapy (CT) in 120 patients with HR-positive/HER2-negative metastatic breast cancer. Key findings include a median time-to-treatment failure (TTF) of 17.2 months for palbociclib+ET versus 6.1 months for CT (HR 0.46, p<0.001) and median progression-free survival (PFS) of 18.7 vs. 7.8 months (HR 0.45, p<0.001), with no significant overall survival difference. The study concludes that palbociclib+ET improves TTF and PFS compared to chemotherapy in this high-risk population.
10.1016/j.esmoop.2026.107707

Quality-of-life assessment in the randomized JBCRG-M06/EMERALD study of eribulin plus dual HER2 blockade in HER2-positive locally advanced or metastatic breast cancer.
BREAST CANCER-TOKYO · Q1 JOURNAL - RANK #26/140
The JBCRG-M06/EMERALD trial (NCT03264547, UMIN000027938) prospectively compared eribulin plus dual HER2 blockade (trastuzumab and pertuzumab) versus taxane plus the same regimen in 427 randomized patients with HER2-positive locally advanced or metastatic breast cancer (LABC/MBC), assessing quality of life (QoL) via EORTC QLQ-C30. The eribulin group showed a longer median time to QoL deterioration (7.16 months, 95% CI 6.28-8.34) versus the taxane group (4.57 months, 95% CI 4.17-6.14; HR 0.80, 95% CI 0.65-0.98, P=0.08), with higher proportions maintaining QoL at 6 months (62.7% vs 43.5%) and 12 months (30.5% vs 25.5%). GHS scores remained stable with eribulin but deteriorated transiently with taxanes. The study concludes eribulin delays QoL deterioration compared to taxanes in HER2-positive LABC/MBC.
10.1007/s12282-026-01876-x

Feasibility and Efficacy of Reiki Versus Massage for Cancer-Related Fatigue in Patients With Breast and Prostate Cancer Receiving Hormone Therapy.
J NATL COMPR CANC NE · Q1 JOURNAL - RANK #17/326TOP-TIER
In this randomized, prospective trial, 87 patients with breast or prostate cancer receiving hormone therapy for at least eight weeks were assigned to massage therapy (two sessions) or Reiki (two or four sessions) to reduce moderate to severe cancer-related fatigue (CRF). The primary outcome was change in Brief Fatigue Inventory total score, analyzed with ANCOVA and reported with within-group effect sizes (Cohen’s d). All interventions significantly reduced CRF from baseline (P<.001), with Reiki producing more substantial symptom improvement (d=0.81–1.49) compared to massage (d=0.50–0.60). Researchers concluded that both interventions are safe, feasible options for managing CRF, with Reiki demonstrating the greatest benefits warranting further large-scale trials.
10.6004/jnccn.2026.7010

First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial.
NAT CANCER · Q1 JOURNAL - RANK #11/326TOP-TIER
The study evaluated the efficacy and safety of first-line durvalumab combined with trastuzumab deruxtecan in 58 women with locally advanced unresectable or metastatic HR-negative, HER2-low breast cancer in a multicenter, open-label phase 1b/2 BEGONIA platform trial. Primary endpoints were objective response rate (ORR) and safety, with secondary endpoints including duration of response (DoR), progression-free survival (PFS), and overall survival (OS). The ORR was 62.1% (95% CI: 48.4-74.5), median DoR was 15.2 months (95% CI: 8.44-not calculable), PFS was 12.6 months (95% CI: 8.4-16.3), and OS was 30.3 months (95% CI: 18.8-not calculable), with a safety profile consistent with individual therapies. The combination demonstrated clinically relevant efficacy with no unexpected toxicities, though the ORR did not meet the protocol-specified objective.
10.1038/s43018-026-01181-8

Short-Term, Cycle-Synchronized Adjunctive Therapy With Crocus Total Glucosides Tablets for Cardiac Protection Against Cancer Therapy-Related Cardiac Dysfunction in Breast Cancer Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.
MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This randomized, double-blind, placebo-controlled trial evaluated cycle-synchronized crocus total glucosides tablets (CTGT) for cardiac protection in 120 breast cancer patients undergoing chemotherapy. The primary endpoints were 6-month change in left ventricular global longitudinal strain (ΔLVGLS%) and left ventricular ejection fraction (ΔLVEF). CTGT significantly attenuated 6-month ΔLVGLS% compared to placebo (-6.55 ± 10.85 vs. -12.63 ± 13.49%, p=0.009), but ΔLVEF did not differ significantly (-3.67 ± 5.75 vs. -2.40 ± 5.47%, p=0.220). CTGT also reduced CTRCD incidence (21.7% vs. 46.7%, p=0.004), demonstrating cardioprotective benefit during chemotherapy.
10.1002/mco2.70780

Jun 01 – Jun 08, 2026

A nurse-led palliative care programme for women receiving palliative chemotherapy for breast cancer.
BMC PALLIAT CARE · Q1 JOURNAL - RANK #29/124
This pilot study tested a nurse-led palliative care program for women with advanced breast cancer receiving palliative chemotherapy in Ghana. Researchers employed an intervention design with pretest-posttest to evaluate changes in unmet care needs, pain, quality of life, and spiritual needs. Results revealed significant improvements, with symptom distress decreasing from an average of 2.98 to 1.97, pain severity from 9.34 to 2.75, and quality of life from 2.79 to 1.94, while spiritual needs increased from 1.04 to 3.00. The authors concluded that nurse-led palliative care effectively addresses multiple dimensions of discomfort, thereby improving overall well-being in advanced breast cancer.
10.1186/s12904-026-02176-z

Photobiomodulation for hormone therapy-induced sexual dysfunction in women with breast cancer: a prospective quasi-experimental clinical study with a parallel observational group.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
This prospective quasi-experimental clinical study investigated photobiomodulation (PBM) for hormone therapy-induced sexual dysfunction in women with breast cancer by enrolling 24 participants who received four weekly blue and red LED PBM sessions, and compared outcomes to eight untreated women observed in parallel. Vaginal pain and sexual function were assessed pre- and post-intervention using the Visual Analog Scale (VAS) and Female Sexual Quotient Questionnaire (QS-F). Post-treatment, the intervention group showed dramatic improvements: mean VAS scores dropped from 9.46 ± 0.98 to 1.04 ± 2.17 and QS-F scores increased from 23.25 ± 23.47 to 87.21 ± 17.93, with p < 0.0001 for both; 79.1% reported absence of pain and 95.8% achieved good to excellent sexual function, while the observational group showed no change. The study concluded PBM was safe, well tolerated, and effective for treating sexual dysfunction in this population.
10.1007/s00520-026-10846-0

Final outcomes of the SOFT and TEXT phase III trials in premenopausal hormone receptor-positive early breast cancer.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This study reports the final 15-year outcomes of the SOFT and TEXT phase III trials evaluating the effects of ovarian function suppression (OFS) combined with tamoxifen (T) or exemestane (E) versus tamoxifen alone in premenopausal women with hormone receptor-positive early breast cancer. The SOFT trial showed improved breast cancer-free interval (BCFI) and overall survival for E+OFS (78.6% BCFI; HR 0.82, CI 0.69-0.98, P=0.03) compared to T+OFS (75.7%) and T alone (72.1%), with age and tumor characteristics influencing outcomes. In combined analysis, among HER2-negative tumors, E+OFS reduced distant recurrence (HR 0.75, CI 0.63-0.90) and had limited survival benefit (HR 0.89, CI 0.74-1.06), especially in high-risk subgroups (e.g., young age or high-grade tumors). The study concludes escalated endocrine therapy provides meaningful survival benefits in select high-risk premenopausal women, emphasizing its benefit in HER2-negative, high-grade tumors or younger patients.
10.1016/j.annonc.2026.05.704

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