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Breast cancerMarch 2026
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Breast Cancer — Monthly Compass
Mar 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in breast cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
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breast cancer updates
Key Highlights
Key Highlights
  • Key Clinical Development Updates
    • FDA accepted and granted Priority Review to the sBLA for Enhertu (fam‑trastuzumab deruxtecan‑nxki) as post‑neoadjuvant therapy for HER2‑positive early breast cancer with residual invasive disease, setting a July 7, 2026 PDUFA target and reviewing under Project Orbis, while a separate neoadjuvant Enhertu followed by THP sBLA remains under review with a May 18, 2026 PDUFA date.
    • FDA scheduled an April 30, 2026 ODAC to discuss NDA 220359 for camizestrant plus a CDK4/6 inhibitor in HR‑positive, HER2‑negative metastatic disease with emergent ESR1 mutation on first‑line endocrine therapy, and separately accepted Celcuity’s gedatolisib NDA with Priority Review and a July 17, 2026 PDUFA goal as the company prepares for a potential Q3 2026 launch pending approval.
  • Key Conference Updates
    • EBCC‑15 reinforced risk‑adapted local therapy with RAPCHEM (BOOG 2010‑03) showing ~2.9% 10‑year locoregional recurrence using post‑neoadjuvant nodal status to tailor radiotherapy—including omission after mastectomy in low‑risk responders—and the ADARNAT pilot suggesting axillary radiotherapy can substitute for dissection with similar short‑term control and numerically less lymphoedema.
    • MBCC discussions, supported by neoCARHP and CompassHER2 (EA1181) analyses, endorsed selective omission of carboplatin from neoadjuvant THP in stage II–III HER2‑positive disease by maintaining pCR rates while reducing grade 3/4 cytopenias, with EFS/OS confirmation pending and caution advised in higher‑risk stage III.
  • Emerging Themes & Macro-Trends
    • ADCs are rapidly expanding across HR+, HER2+, and TNBC with movement toward first‑line TNBC and earlier‑stage evaluation, sharpening sequencing decisions that depend on biomarkers and prior therapy and including emerging combinations such as sacituzumab govitecan plus pembrolizumab for PD‑L1‑positive TNBC.
    • Strategy is coalescing around “right‑sizing” therapy and durability, with trials embedding ctDNA and endocrine‑resistance biomarkers and late‑toxicity tracking, while priority‑review trajectories for ADCs could accelerate first‑line uptake and reimbursement decisions.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-03-01 and 2026-03-31 about breast cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Daiichi Sankyo and AstraZeneca announced the FDA accepted and granted Priority Review to their sBLA for Enhertu (fam‑trastuzumab deruxtecan‑nxki) as post‑neoadjuvant therapy for HER2‑positive early breast cancer with residual invasive disease; the PDUFA target action date is July 7, 2026. The companies also noted the sBLA for neoadjuvant Enhertu followed by THP remains under FDA review with a PDUFA date of May 18, 2026, and the post‑neoadjuvant sBLA is being reviewed under Project Orbis. (daiichisankyo.us)¹ (read more)
  • FDA posted an ODAC meeting announcement (content current as of March 9, 2026) scheduling an April 30, 2026 discussion of NDA 220359 for AstraZeneca’s camizestrant tablets in combination with a CDK4/6 inhibitor for adults with HR‑positive, HER2‑negative, locally advanced or metastatic breast cancer with an emergent ESR1 mutation on first‑line endocrine‑based therapy. The notice includes meeting logistics and the docket number (FDA‑2026‑N‑1867) for public comments. (fda.gov)² (read more)
  • Celcuity’s March 25 corporate update reiterated the FDA accepted its NDA for gedatolisib in HR+/HER2‑, PIK3CA wild‑type advanced breast cancer, granted Priority Review, and assigned a PDUFA goal date of July 17, 2026. The company also highlighted recent VIKTORIA‑1 cohort publications while preparing for a potential Q3 2026 launch, pending approval. (globenewswire.com)³ (read more)
  • Greenwich LifeSciences reported open‑label FLAMINGO‑01 data and noted that GLSI‑100 (GP2 + GM‑CSF) is Fast Track designated by FDA. The update, focused on recurrence‑rate trends in the non‑HLA‑A*02 arm, reaffirmed the ongoing Phase III program in HER2‑positive early breast cancer. (globenewswire.com)⁴ (read more)
  • Greenwich LifeSciences provided an AACR 2026 preview stating its Phase III FLAMINGO‑01 trial of Fast Track–designated GLSI‑100 will have new immune‑response and design‑update posters. The company emphasized FLAMINGO‑01’s goal of preventing breast cancer recurrences in high‑risk, HER2‑positive patients post‑standard therapy. (globenewswire.com)⁵ (read more)
  • Greenwich LifeSciences announced activation of additional City of Hope sites for the Phase III FLAMINGO‑01 trial evaluating Fast Track–designated GLSI‑100 in HER2‑positive early breast cancer at high risk of recurrence. The expansion increases U.S. study coverage while the program advances toward key interim analyses. (globenewswire.com)⁶ (read more)
Conference
Major Conference Updates
Conference Information
  • 43rd Annual Miami Breast Cancer Conference (MBCC), Miami Beach, Florida; March 5–8, 2026. 15th European Breast Cancer Conference (EBCC-15), Barcelona, Spain; March 25–27, 2026. (read more)
  • Overall: March meetings emphasized “right-sizing” therapy—de-escalating when biology allows and personalizing when risk warrants—while operationalizing next-wave modalities (ADCs) and adherence-enabling symptom control. (read more)
  • Theme 1: Risk‑Adapted Radiotherapy and Axillary De‑escalation
    • Significance: Long-term and prospective data at EBCC-15 reinforced scaling local therapy to pathologic response, targeting durable control while minimizing morbidity (e.g., lymphoedema). (read more)
    • Mechanism insights / clinical impact: “RAPCHEM: BOOG 2010-03” showed 10‑year locoregional recurrence ~2.9% using post‑neoadjuvant nodal status to tailor fields/intensity—including omission after mastectomy in low‑risk responders; ADARNAT pilot suggests axillary radiotherapy can substitute for dissection with similar short‑term cancer control and numerically less lymphoedema. (read more)
    • Patient populations affected: Early breast cancer receiving neoadjuvant therapy (cT1‑2N1 in RAPCHEM; node‑positive with 1–2 positive sentinel nodes post‑neoadjuvant in ADARNAT), primarily informing surgical/RT decisions in the early setting. (read more)
  • Theme 2: Neoadjuvant HER2+ Chemo De‑escalation (Carboplatin Omission)
    • Significance: MBCC discussions highlighted moving from “maximal” to “optimal” chemotherapy—preserving pCR while reducing hematologic toxicity and treatment burden. (read more)
    • Mechanism insights / clinical impact: Phase 3 “neoCARHP” and CompassHER2 (EA1181) biomarker analyses support THP (taxane + trastuzumab + pertuzumab) without carboplatin in selected HER2+ disease; comparable pCR with fewer grade 3/4 cytopenias, with EFS/OS confirmation pending. (read more)
    • Patient populations affected: Stage II–III HER2+ (especially IHC 3+, lower‑risk) in the neoadjuvant setting; caution in higher‑risk stage III while awaiting survival data. (read more)
  • Theme 3: ADC Expansion and Sequencing Debates
    • Significance: MBCC faculty and late‑March expert programming underscored ADCs’ rapid reach across HR+, HER2+, and TNBC—including movement to first‑line TNBC and exploration in earlier stages—making sequencing a front‑burner issue. (read more)
    • Mechanism insights / clinical impact: HER2‑ and TROP2‑directed payload delivery (e.g., trastuzumab deruxtecan; sacituzumab govitecan‑hziy; datopotamab deruxtecan‑dlnk) with emerging IO combinations (SG + pembrolizumab for PD‑L1+ TNBC) drive efficacy but necessitate biomarker‑ and history‑informed placement. (read more)
    • Patient populations affected: Metastatic TNBC (first‑line and beyond), HR+ and HER2+ across lines, with earlier‑stage trials on the horizon; global applicability with local access/approval nuances. (read more)
  • Theme 4: Symptom Control as an Adherence Enabler (Elinzanetant)
    • Significance: Addressing vasomotor symptoms improves quality of life and may sustain endocrine therapy adherence—an under‑leveraged driver of outcomes. (read more)
    • Mechanism insights / clinical impact: In OASIS‑4 subgroup analysis, neurokinin antagonist elinzanetant reduced frequency/severity of VMS across tamoxifen, aromatase inhibitors, and ovarian suppression, with mostly mild AEs. (read more)
    • Patient populations affected: ER+ patients on adjuvant or metastatic endocrine therapy experiencing moderate‑to‑severe VMS; potential to broaden via combinations with targeted agents. (read more)
  • Significance
    • Expected clinical or translational readouts: Randomized U.S. de‑escalation RT data in ~3 years; ADARNAT phase III completion plus 5‑year follow‑up; longer‑term neoCARHP survival; expanding ADC/IO combinations. (read more)
    • Regulatory or policy implications: ADCs (e.g., datopotamab deruxtecan‑dlnk) under priority review trajectories could accelerate first‑line TNBC uptake and reimbursement decisions. (read more)
    • Potential shifts in standard of care: Broader adoption of risk‑adapted RT/axillary strategies; selective carboplatin omission in HER2+ neoadjuvant; earlier ADC integration contingent on survival/SAFETY maturity. (read more)
    • Strategic implications: Portfolio value for HER2/TROP2 ADCs and adherence enablers; trials should embed ctDNA/endocrine resistance markers and late toxicity tracking to defend de‑escalation and optimize ADC sequencing. (read more)
Publications Related to Approved Drugs
Unknown Drug
There are no new publication updates during the 2026-03-01 to 2026-03-31 for breast cancer.
New Publications Related to Drugs in Clinical Trial Development
Phase 3
Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02. The addition of tucatinib to T-DM1 significantly improved progression-free survival in patients with previously treated HER2-positive locally advanced or metastatic breast cancer, including those with brain metastases. This combination demonstrated a manageable safety profile, supporting its potential as a robust therapeutic strategy in this challenging patient population. ()
PHASE1, PHASE2
Phase II study of olaparib and durvalumab in patients with metastatic castration-resistant prostate cancer. The combination of olaparib and durvalumab showed modest clinical activity in an HRR-unselected metastatic castration-resistant prostate cancer population, with enhanced benefit observed in patients harboring BRCA2 variants. Integrated circulating tumor DNA and peripheral immune analyses highlight the importance of refining molecular and immune selection strategies to optimize combination therapies. ()
PHASE1, PHASE2
Durvalumab and cediranib with and without olaparib in recurrent ovarian cancer: a phase II proof-of-concept study. In recurrent ovarian cancer, the combination of durvalumab and cediranib met its primary objective response rate endpoint, whereas the triplet combination with olaparib did not. Exploratory molecular profiling identified immune activation and metabolic pathway enrichment in exceptional responders, offering potential predictive signatures for future targeted immunotherapy trials. ()
Phase 3
VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. The addition of the pan-PI3K/mTOR inhibitor gedatolisib to fulvestrant, with or without palbociclib, significantly reduced the risk of disease progression or death in patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer following prior CDK4/6 inhibitor therapy. These findings highlight a promising, comprehensive PI3K pathway blockade strategy with a manageable safety profile for overcoming endocrine resistance. ()
Phase 2
Analysis of the Radiosensitivity Index in Paired Preneoadjuvant and Postneoadjuvant Therapy Triple-Negative Breast Cancer. Pretreatment Radiosensitivity Index (RSI) cluster identity is strongly associated with the degree of immune enrichment and the likelihood of achieving a pathologic complete response to neoadjuvant systemic therapy in triple-negative breast cancer. Notably, initially immune-enriched tumors that fail to achieve a complete response exhibit a significant decrease in predicted radiosensitivity, suggesting a need for adaptive therapeutic strategies. ()
Phase 2
ToPCourT protocol: a phase II trial of Trilaciclib, Pembrolizumab, gemcitabine, and Carboplatin in locally advanced/unresectable or metastatic Triple-negative breast cancer. The ToPCourT phase II trial protocol outlines a novel approach utilizing the transient CDK4/6 inhibitor trilaciclib to enhance and prolong antitumor responses when combined with pembrolizumab and chemotherapy in advanced triple-negative breast cancer. This strategy aims to mitigate chemotherapy-induced toxicity while potentially overcoming resistance mechanisms in a clinically aggressive malignancy. ()
N/A
Intraoperative breast cancer margin evaluation using fluorescence imaging with intravenous injection of indocyanine green (BREASTIFLU-1): study protocol for a randomized diagnostic accuracy trial of quantitative dose-timing assessment. The BREASTIFLU-1 trial aims to optimize the diagnostic accuracy of indocyanine green fluorescence imaging for intraoperative margin assessment during breast-conserving surgery by evaluating various intravenous doses and administration timings. Establishing standardized protocols for this technique could significantly reduce the rate of positive surgical margins and improve surgical outcomes in early-stage breast cancer. ()
Phase 2
ctDNA and tumor-based biomarkers of giredestrant response in acelERA breast cancer. Biomarker analysis from the acelERA trial demonstrates that tumor estrogen receptor (ER) transcriptional activity and circulating tumor DNA (ctDNA) dynamics effectively stratify responses to endocrine therapy, including the oral selective ER degrader giredestrant. The integration of early ctDNA clearance and ER activity signatures provides a robust framework for personalizing treatment and predicting rapid clinical progression in advanced ER+ breast cancer. ()
Phase 2
A phase II randomized placebo-controlled study of fisetin to improve physical function in breast cancer survivors: the TROFFi study rationale and trial design. The TROFFi study is a pioneering phase II trial evaluating the oral senolytic agent fisetin to mitigate persistent physical function decline in postmenopausal breast cancer survivors treated with chemotherapy. By targeting chemotherapy-induced cellular senescence, this approach addresses a critical unmet clinical need and could establish a new paradigm for improving survivorship quality of life. ()
Phase 2
A phase II study of atezolizumab in combination with stereotactic radiation for patients with triple-negative breast cancer and brain metastasis. Concurrent administration of atezolizumab and stereotactic radiosurgery proved feasible in patients with triple-negative breast cancer and brain metastases, though overall disease outcomes remained poor. These findings underscore the persistent and significant unmet medical need for developing more effective therapeutic combinations for this high-risk patient population. ()
Phase 3
Bireociclib Plus Fulvestrant in Advanced Breast Cancer After Endocrine Progression: The BRIGHT-2 Phase 3 Randomized Clinical Trial. The final analysis of the BRIGHT-2 trial confirms that the addition of the CDK4/6 inhibitor bireociclib to fulvestrant significantly prolongs progression-free survival in patients with HR+/HER2- advanced breast cancer who progressed on prior endocrine therapy. This combination offers a highly effective and well-tolerated treatment option, with consistent benefits observed across multiple high-risk patient subgroups. ()
PHASE1, PHASE2
Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study. In the phase II ASCENT-J02 study, sacituzumab govitecan demonstrated manageable safety and overall efficacy consistent with global trials in Japanese patients with previously treated HR+/HER2- metastatic breast cancer. Although the primary objective response rate endpoint by independent review was not statistically met, the clinical activity supports broader access to this Trop-2-directed antibody-drug conjugate in this population. ()
Phase 3
Health-related quality of life with first- vs second-line CDK4/6 inhibitor use in advanced breast cancer: results from the SONIA trial. Results from the SONIA trial indicate that health-related quality of life remains comparable whether CDK4/6 inhibitors are administered in the first- or second-line setting for advanced breast cancer, despite higher toxicity rates associated with first-line use. These findings provide critical patient-centered data to inform strategic treatment sequencing and optimize the balance between efficacy and quality of life. ()
Phase 2
Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer. Incorporating dynamic contrast-enhanced MRI vascular texture dynamics at midtreatment significantly enhances the prediction of pathologic complete response in HER2-negative breast cancer compared to standard clinical and functional tumor volume features alone. These radiomic biomarkers correlate with key biological pathways, offering a non-invasive tool to refine neoadjuvant treatment monitoring and personalization. ()
Phase 2
MRI-based personalisation of neoadjuvant chemotherapy duration in HER2-positive early breast cancer (TRAIN-3): primary results from a multicentre, single-arm, phase 2 study. The TRAIN-3 study demonstrates that MRI-guided optimization of neoadjuvant chemotherapy duration yields favorable 3-year event-free survival outcomes in patients with stage II-III HER2-positive breast cancer. This personalized approach successfully reduces treatment burden and minimizes toxicity for patients achieving rapid radiological responses, preserving quality of life without compromising efficacy. ()
Phase 2
Circulating tumor DNA in neoadjuvant endocrine therapy for early breast cancer. Analysis from the PELOPS trial reveals that the detection of circulating tumor DNA (ctDNA) prior to neoadjuvant endocrine therapy is associated with higher pathological stage and residual cancer burden in HR+/HER2- breast cancer. Furthermore, persistent ctDNA post-treatment indicates a higher risk of distant recurrence, highlighting its potential utility in guiding surgical and long-term therapeutic decisions. ()
Phase 2
Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial. Data from the PELOPS trial indicate that the addition of palbociclib to neoadjuvant endocrine therapy does not significantly impact pathologic nodal outcomes in HR+/HER2- breast cancer. Importantly, among patients with residual nodal disease, the extent of axillary surgery did not appear to affect local-regional recurrence or breast cancer-specific survival, suggesting a need for refined surgical guidelines in this setting. ()
Phase 2
Surgeon Perspectives on Axillary Management Following Neoadjuvant Endocrine Therapy: Results from a Qualitative Substudy of the PELOPS Trial. A qualitative substudy of the PELOPS trial highlights significant variability in surgeon decision-making regarding axillary lymph node dissection following neoadjuvant endocrine therapy, driven by differing views on its diagnostic versus therapeutic value. These findings underscore the urgent need for dedicated clinical trials to establish evidence-based guidelines for managing residual nodal disease in this specific patient population. ()
PHASE1, PHASE2
Phase 1 study of ceralasertib, an ATR kinase inhibitor, in combination with durvalumab in patients with recurrent or metastatic NSCLC or HNSCC. The combination of the ATR kinase inhibitor ceralasertib and the PD-L1 inhibitor durvalumab demonstrated a manageable safety profile and encouraging preliminary antitumor activity in heavily pretreated patients with advanced NSCLC and HNSCC. Pharmacodynamic evidence of target engagement supports further clinical development of this novel combination strategy to overcome immune resistance. ()
Phase 2
Prospective pilot study with [89Zr]Zr-girentuximab PET/CT: CA-IX imaging in metastatic triple negative breast cancer (OPALESCENCE). The OPALESCENCE pilot study demonstrates that [89Zr]Zr-girentuximab PET/CT is a highly sensitive imaging modality for detecting CA-IX expression in metastatic triple-negative breast cancer, including the identification of brain metastases not seen on standard FDG PET/CT. This novel imaging approach offers significant promise for developing targeted theranostic strategies in a disease with limited treatment options. ()
Phase 2
Analysis of the Radiosensitivity Index in Paired Preneoadjuvant and Postneoadjuvant Therapy Triple-Negative Breast Cancer. Pretreatment Radiosensitivity Index (RSI) cluster identity is strongly associated with the degree of immune enrichment and the likelihood of achieving a pathologic complete response to neoadjuvant systemic therapy in triple-negative breast cancer. Notably, initially immune-enriched tumors that fail to achieve a complete response exhibit a significant decrease in predicted radiosensitivity, suggesting a need for adaptive therapeutic strategies. ()
PHASE1, PHASE2
CSF1R Inhibition with Chemotherapy Relieves Systemic Immune Suppression in Patients with Metastatic Triple-Negative Breast Cancer and Boosts anti-PD-1 Efficacy in Transgenic Mammary Tumors. Combining the CSF1R inhibitor pexidartinib with eribulin in metastatic triple-negative breast cancer demonstrated clinical benefit and increased peripheral leukocyte activation, including the enrichment of memory T cells. Preclinical models further suggest that this strategy relieves systemic immune suppression, providing a strong rationale for combining CSF1R inhibition with PD-1 blockade to enhance therapeutic efficacy. ()
Phase 3
DXA-Derived Abdominal Adiposity and Obesity-Related Cancer Risk Among Postmenopausal Women in the Women's Health Initiative. Analysis of the Women's Health Initiative cohort reveals that higher DXA-derived visceral abdominal adiposity is strongly and independently associated with an increased risk of obesity-related cancers in postmenopausal women. Incorporating precise, imaging-based body composition metrics could significantly improve cancer risk stratification and inform targeted prevention strategies beyond traditional BMI measurements. ()
Phase 3
Biomarkers for dietary fatty acid densities among postmenopausal United States females derived using a habitual-diet human feeding study. A human feeding study within the Women's Health Initiative successfully developed objective biomarker equations for specific dietary fatty acid densities using serum and urine metabolite profiles. These validated biomarkers provide a reliable tool for accurately assessing dietary fatty acid intake, facilitating more robust investigations into the relationship between diet and chronic disease risk in postmenopausal women. ()
Phase 2
OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer. The phase II OPERA study demonstrated that DHP107, a novel oral paclitaxel formulation, provides comparable efficacy and a similar safety profile to standard intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer. This oral alternative offers a feasible and potentially more convenient treatment option, eliminating the need for Cremophor EL and its associated premedications. ()
Phase 1
Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients With Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies. A combined analysis of early-phase trials indicates that the dual HER2-targeted bispecific antibody zanidatamab delivers meaningful clinical benefit and durable responses in patients with previously treated, HER2-positive salivary gland cancer. The manageable safety profile and observed tumor reductions support the continued evaluation of zanidatamab as a targeted therapeutic option for this rare and challenging malignancy. ()
Early Phase 1
Optimized Detection of Left Ventricular Hyperpolarized [1-13C]Pyruvate Signal in Human Cardiac Metabolic Imaging. A novel mathematical model utilizing exponential fitting and thresholding significantly improves the reliable quantification of the left ventricular blood pool signal in hyperpolarized [1-13C]pyruvate cardiac metabolic imaging. This optimized, semiautomated approach provides a more robust correlation with downstream metabolic outcomes, enhancing the precision of non-invasive cardiac metabolic assessments in clinical research. ()
Phase 2
KEYLYNK-009: Pembrolizumab plus Olaparib in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer after Clinical Benefit from First-Line Pembrolizumab plus Chemotherapy. In the KEYLYNK-009 trial, switching to pembrolizumab plus olaparib maintenance therapy resulted in similar progression-free and overall survival compared to continuing pembrolizumab plus chemotherapy in patients with advanced triple-negative breast cancer. Notably, a positive trend in survival outcomes for patients with BRCA mutations suggests this chemotherapy-free regimen may be a viable maintenance strategy for this specific molecular subgroup. ()
Phase 2
Molecular profiling of chemotherapy-resistant breast cancer reveals DNA methylation remodeling associated with the acquisition of paclitaxel resistance. Comprehensive molecular profiling reveals that the acquisition of paclitaxel resistance in breast cancer is driven by extensive genomic and epigenetic remodeling, including significant DNA methylation changes. While the DNA methyltransferase inhibitor decitabine can partially restore chemosensitivity and modulate the tumor phenotype, overcoming clinical resistance will likely require rational, multi-targeted drug combinations. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast cancer updated from 2026-03-01 to 2026-03-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1-1---2
Not Yet Recruiting431816133
Recruiting3732542252152
Available-------
Approved for Marketing-------
Active, Not Recruiting131231112-69
Completed22---26
Total57491044435262
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Rosuvastatin, Capivasertib NCT07088913 COMPLETED An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin (a BCRP, OATP1B1 and OATP1B3 Sensitive Substrate) in Healthy Participants 2026-02-20
Fluorouracil, Leucovorin, AB598, Zimberelimab, Oxaliplatin NCT05891171 ACTIVE_NOT_RECRUITING A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies 2026-03
Letrozole LEBE 150 mg, Letrozole LEBE 75 mg, Letrozole LEBE 225 mg NCT06315205 ACTIVE_NOT_RECRUITING A Phase I, Open Label, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Intramuscular Injections of Letrozole LEBE at Different Strengths in Voluntary Healthy Post-Menopausal Women. 2026-03
Paclitaxel, MDM2/MDMX Inhibitor ALRN-6924 NCT03725436 COMPLETED A Phase 1b Study of ALRN-6924 in Combination With Paclitaxel in Wild-Type TP53 Advanced or Metastatic Solid Tumors Including Estrogen-Receptor Positive Breast Cancer 2026-03-11
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Carvedilol, Empagliflozin NCT06844669 ACTIVE_NOT_RECRUITING HER2HEART-US: Primary Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy: a Pilot 2x2 Factorial Randomized Controlled Trial 2026-05-05
Entrectinib NCT02568267 ACTIVE_NOT_RECRUITING An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements 2026-05-14
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Cyclophosphamide, Paclitaxel, : Bevacizumab, Doxorubicin Hydrochloride NCT00433511 ACTIVE_NOT_RECRUITING A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer 2026-02-22
Nab-Paclitaxel, Capecitabine, Trastuzumab deruxtecan, Paclitaxel NCT04494425 ACTIVE_NOT_RECRUITING A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06) 2026-06-19
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Folic Acid Tablet NCT04024254 COMPLETED A Study of Serum Folate Levels in Patients With Treated With Olaparib. 2025-12-31
PVB Protocol, PECS-1, Serratus NCT04016376 COMPLETED Cluster-Randomized, Prospective Assessment of Postoperative Pain Management in Patients Undergoing Bilateral Mastectomy With Immediate Reconstruction With Tissue Expander (BMWRw/TE) Using Preoperative Paravertebral (PVB), Serratus+PECS-1, or PVB+PECS-1 Nerve Blocks 2026-02-25
Paclitaxel NCT05183126 RECRUITING Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer 2026-06
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