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Phase 3 Trial Evaluates Folic Acid Supplementation for Hot Flash Management in Premenopausal Breast Cancer Patients on Adjuvant Endocrine Therapy

A completed phase 3 interventional trial conducted at Future University in Egypt assessed whether folic acid supplementation at 1 mg/day or 5 mg/day can reduce the frequency or severity of hot flashes induced by adjuvant endocrine therapy in premenopausal breast cancer patients. Full efficacy results have not yet been publicly reported.

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Phase 1/2 IL Believe Trial Evaluates TransCon IL-2 β/γ Monotherapy and Combination Regimens Across Multiple Advanced Solid Tumors

The IL Believe trial, sponsored by Ascendis Pharma, is a first-in-human Phase 1/2 dose-escalation and expansion study assessing the safety and tolerability of TransCon IL-2 β/γ—a novel investigational IL-2 prodrug—as monotherapy and in combination with pembrolizumab, TransCon TLR7/8 agonist, trastuzumab, T-DM1, or chemotherapy in adults with locally advanced or metastatic solid tumors. The trial is currently active but no longer enrolling.

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Phase 4 Safety Trial of Trastuzumab Deruxtecan Targets Indian Patients With HER2-Positive Metastatic Breast Cancer

AstraZeneca is conducting a prospective, multicenter, single-arm Phase 4 trial evaluating the safety profile of trastuzumab deruxtecan (T-DXd) specifically in Indian patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti-HER2–based regimen. The trial is currently active but no longer enrolling.

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Tissue-Free Epigenomic ctDNA Assay at 2-Year Post-Chemotherapy Landmark Predicts Recurrence Risk in Early-Stage Breast Cancer

A tissue-free epigenomic circulating tumor DNA assay demonstrated strong prognostic value when applied at a 2-year post-adjuvant chemotherapy landmark in early-stage breast cancer, identifying individuals at elevated recurrence risk who may be candidates for early intervention. The findings, published in JCO Precision Oncology, support ctDNA-based risk stratification independent of tumor tissue availability.

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PET-Guided Response Adaptation in Stage II/III TNBC: Phase 2 Pilot Evaluates Early Imaging and Biomarker Dynamics During Pembrolizumab-Based Neoadjuvant Chemotherapy

A phase 2 pilot trial at Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center is enrolling patients with stage II/III triple-negative breast cancer to assess whether early PET imaging and biomarker changes after one cycle of paclitaxel/carboplatin/pembrolizumab can guide individualized neoadjuvant sequencing and rescue strategies.

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Phase 1b/2 Trial of Zanidatamab Combinations Completed in HER2-Positive Breast and Gastric/GEJ Cancers

A completed Phase 1b/2 interventional trial evaluated the anti-HER2 bispecific antibody zanidatamab combined with docetaxel in HER2-positive breast cancer, and with tislelizumab plus chemotherapy (capecitabine/oxaliplatin) in HER2-positive gastric or gastroesophageal junction adenocarcinoma. The study assessed safety, tolerability, pharmacokinetics, and preliminary antitumor activity across both tumor types.

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SWOG S0221 Phase III Trial Compares AC Dosing Schedules Followed by Paclitaxel in High-Risk Resected Breast Cancer

The SWOG S0221 randomized phase III trial is evaluating two distinct doxorubicin/cyclophosphamide (AC) dosing schedules—continuous versus dose-dense biweekly—each followed by paclitaxel administered either every two weeks or weekly for 12 weeks, as post-operative adjuvant chemotherapy in node-positive or high-risk node-negative breast cancer. The trial is currently active but no longer enrolling.

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Physical Exercise Emerges as Most Promising Non-Pharmacological Strategy for QoL in HR+ Breast Cancer Survivors on Adjuvant Endocrine Therapy

A systematic review of seven RCTs found that non-pharmacological interventions—particularly structured physical exercise—may improve overall quality of life and specific QoL domains in women with hormone receptor-positive breast cancer receiving adjuvant endocrine therapy, though high methodological heterogeneity limits definitive conclusions.

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TOUCH Trial Tests Chemotherapy-Free Neoadjuvant Strategy in HR+/HER2+ Early Breast Cancer

The completed phase II TOUCH trial evaluated whether palbociclib combined with letrozole and dual HER2 blockade (trastuzumab plus pertuzumab) could replace paclitaxel-based chemotherapy in the neoadjuvant setting for postmenopausal women with HR+/HER2+ early breast cancer. The randomized, open-label, multicentre design aimed to determine whether a chemotherapy-sparing regimen could achieve comparable efficacy.

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AI-Based TIL Scoring Shows Predictive Value in HER2-Positive Early Breast Cancer: APHINITY Secondary Analysis

A secondary analysis of the phase III APHINITY trial evaluated manual, digital, and AI-driven tumour-infiltrating lymphocyte scoring methods, assessing their comparative predictive utility in HER2-positive early breast cancer. Findings suggest AI-based TIL quantification may offer clinically meaningful prognostic and predictive information in this setting.

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INNOVATE Trial Enrolling HER2-Positive Early Breast Cancer Patients for Biomarker-Guided Neoadjuvant Regimen Optimization

The phase 2 BRE-10 INNOVATE trial is actively recruiting adults with IHC/FISH-confirmed HER2-positive early-stage breast cancer to evaluate whether MammaPrint®/BluePrint® genomic profiling can optimize neoadjuvant chemotherapy and HER2-targeted regimen selection. The interventional study is led by the University of Illinois at Chicago.

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Phase 2 Trial Evaluates Serplulimab Plus Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Early-Stage HR+/HER2− Breast Cancer

A phase 2 interventional trial at Henan Cancer Hospital is actively recruiting to assess the efficacy and safety of the anti-PD-1 antibody serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant setting for early-stage HR+/HER2− breast cancer. The study addresses a gap in immunotherapy integration within this historically chemotherapy-dependent subtype.

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Phase 2 Trial Evaluates Dose-Dense CMF as Anthracycline-Sparing Option in Early-Stage Breast Cancer for Patients Aged 70 and Older

A Phase 2 interventional trial at Memorial Sloan Kettering Cancer Center is actively enrolling adults aged 70 and older with early-stage breast cancer to assess the feasibility of dose-dense CMF (cyclophosphamide, methotrexate, fluorouracil) as an alternative to standard AC-based (doxorubicin/cyclophosphamide) chemotherapy regimens.

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Tumor Microenvironment Composition Predicts Long-Term Tamoxifen Benefit in Postmenopausal ER+/HER2− Breast Cancer

A secondary analysis of the randomized STO-3 trial found that immune, endothelial, and fibroblast cell abundances within the tumor microenvironment significantly modulate long-term clinical benefit from tamoxifen in postmenopausal ER+/HER2− breast cancer. These findings implicate both immune and stromal compartments as determinants of endocrine therapy efficacy.

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Phase III UNIRAD Trial Evaluates Everolimus Added to Adjuvant Endocrine Therapy in High-Risk ER+/HER2− Breast Cancer

The UNIRAD trial is a randomized, double-blind, multicenter Phase III study assessing whether adding everolimus to standard adjuvant endocrine therapy improves outcomes in women with ER+/HER2− primary breast cancer at high relapse risk due to extensive nodal involvement. The trial targets patients who have completed at least one year of adjuvant hormone therapy without disease recurrence.

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Phase 3 Trial Evaluates Prosigna-Guided Chemotherapy De-escalation in Premenopausal HR+/HER2− Early Breast Cancer

A UNICANCER-sponsored phase 3 interventional trial is now recruiting premenopausal women with HR+/HER2− early breast cancer to assess whether PAM50 genomic scoring (Prosigna®) can safely guide omission of adjuvant chemotherapy in favor of optimized endocrine therapy with ovarian function suppression. The primary endpoint is invasive disease-free survival compared against systematic chemo-endocrine therapy.

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Circulating microRNAs and Lipidomic Biomarkers Show Diagnostic Promise for Early Breast Cancer, But Clinical Translation Remains Premature

A systematic review and meta-analysis published in PLOS ONE found that circulating microRNAs and lipidomic/metabolomic biomarkers demonstrate strong aggregate diagnostic performance for breast cancer detection, yet substantial heterogeneity and reliance on retrospective case-control designs preclude near-term clinical deployment.

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Phase 2 Trial Evaluates PF-07220060 Plus Letrozole in Neoadjuvant Setting for HR+/HER2− Breast Cancer in Postmenopausal Women

A completed Pfizer-sponsored Phase 2 randomized trial assessed the CDK inhibitor PF-07220060 combined with letrozole versus letrozole monotherapy as short-course neoadjuvant therapy in postmenopausal women with HR+/HER2− breast cancer. The 14-day interventional window incorporated mandatory Day 14 tumor biopsy to evaluate pharmacodynamic and safety endpoints.

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Eribulin Mesylate vs. Taxanes Combined with Dual HER2 Blockade in First-Line Metastatic Breast Cancer: Updated EMERALD Subgroup Data

Updated subgroup analyses from the phase III JBCRG-M06/EMERALD trial compare eribulin mesylate against docetaxel or paclitaxel, each combined with trastuzumab and pertuzumab, as first-line therapy in HER2-positive locally advanced or metastatic breast cancer. The data provide additional granularity on efficacy and tolerability across clinically relevant subpopulations.

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Phase II MolecularPCR Trial Evaluates De-escalated Adjuvant Therapy in pCR/MRD-Negative Early HER2+ and TNBC

The MolecularPCR Trial is a Phase II interventional study at MD Anderson Cancer Center investigating whether adjuvant therapy intensity can be safely reduced in patients with early HER2-positive breast cancer or TNBC who achieved pathologic complete response after neoadjuvant therapy and test negative for circulating molecular residual disease. The trial is currently recruiting.

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CompassHER2 RD Trial Evaluates T-DM1 Plus Tucatinib for Relapse Prevention in High-Risk HER2-Positive Residual Disease

The CompassHER2 RD phase III randomized trial is investigating whether adding tucatinib to trastuzumab emtansine (T-DM1) improves relapse-free outcomes compared with T-DM1 alone in patients with HER2-positive breast cancer and residual disease following neoadjuvant therapy. The double-blinded trial is currently active but no longer enrolling.

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Phase III lidERA Trial Evaluates Giredestrant as Adjuvant Therapy in ER+/HER2− Early Breast Cancer

The lidERA Breast Cancer trial is a global Phase III randomized study comparing adjuvant giredestrant—an oral selective estrogen receptor covalent antagonist (SERCA)—against physician's choice of endocrine monotherapy in medium- and high-risk Stage I–III ER+/HER2− early breast cancer. The trial, sponsored by Hoffmann-La Roche, is currently active but no longer enrolling.

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Phase III Trial Evaluates Bevacizumab Addition to AC-Paclitaxel Adjuvant Regimen in High-Risk Breast Adenocarcinoma

A double-blind, randomized phase III trial sponsored by the National Cancer Institute is investigating whether adding bevacizumab to standard adjuvant doxorubicin/cyclophosphamide followed by paclitaxel improves outcomes in lymph node-positive or high-risk lymph node-negative breast adenocarcinoma. The trial is currently active but no longer enrolling participants.

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HER2CLIMB-05 Phase 3 Trial Evaluates Tucatinib as Maintenance Therapy in Metastatic HER2+ Breast Cancer

The HER2CLIMB-05 trial is a randomized, double-blind, phase 3 study assessing tucatinib versus placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic or locally advanced unresectable HER2-positive breast cancer. The trial, sponsored by Seagen (a Pfizer subsidiary), is currently active but no longer enrolling participants.

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CAPItello-292 Trial Evaluates Capivasertib Triple Combination With CDK4/6 Inhibitors and Fulvestrant in HR+/HER2- Advanced Breast Cancer

AstraZeneca's Phase Ib/III CAPItello-292 trial is actively enrolling participants to assess whether adding the AKT inhibitor capivasertib to CDK4/6 inhibitor plus fulvestrant backbone therapy improves outcomes in locally advanced or metastatic HR+/HER2- breast cancer. The randomized, open-label design tests capivasertib in combination with palbociclib, ribociclib, or abemaciclib against CDK4/6 inhibitor–fulvestrant doublet therapy alone.

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Phase III Trial Evaluates TQB3616 Plus Endocrine Therapy as Adjuvant Strategy in HR+/HER2− Breast Cancer

A randomized, double-blind, placebo-controlled Phase III trial is assessing the efficacy and safety of TQB3616 capsules combined with standard endocrine therapy in approximately 1,946 women with HR-positive, HER2-negative breast cancer in the adjuvant setting. The trial, sponsored by Chia Tai Tianqing Pharmaceutical Group, is currently active but no longer enrolling.

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