OncRef
Skip to newsletter content
|
Breast cancerApril 2026
0:00 / 5:11
Breast Cancer — Monthly Compass
Apr 01–30, 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.
Built for oncologists OncRef Curated Oncology Intelligence Layer
breast cancer updates
Key Highlights
Key Highlights
  • Important Drug Publication Updates
    • A U.S. payer–perspective analysis concluded that capivasertib plus fulvestrant, while increasing quality-adjusted life-years in PIK3CA/AKT1/PTEN‑altered HR+/HER2‑ advanced breast cancer, is not cost‑effective at current wholesale acquisition cost, indicating a need for pricing adjustments or value‑based contracting to achieve standard willingness‑to‑pay thresholds.
    • A post‑hoc analysis of DESTINY‑PanTumor02 found only moderate concordance between local and central HER2 IHC, underscoring the necessity for validated diagnostics and standardized algorithms to accurately select patients for trastuzumab deruxtecan.
  • Key Clinical Development Updates
    • On April 30, 2026, FDA’s ODAC voted 6–3 against the benefit–risk profile for AstraZeneca’s camizestrant plus a CDK4/6 inhibitor for first‑line, ESR1‑mutation–guided HR+/HER2‑ advanced breast cancer (NDA 220359), concluding the data did not demonstrate a clinically meaningful benefit.
    • Mabwell initiated a Phase 3 trial of its Nectin‑4–targeting ADC 9MW2821 in TNBC under FDA Fast Track while Olema advanced Fast Tracked palazestrant with OPERA‑01/02 ongoing and OP‑3136 in Phase 1 post‑IND, Boundless Bio progressed BBI‑940 after January 2026 IND acceptance into the KOMODO‑1 first‑in‑human study for ER+/HER2‑ and TNBC‑LAR, and Telomir secured IND clearance for Telomir‑Zn enabling a Phase 1/2 start in advanced/metastatic TNBC in 1H 2026.
  • Important Clinical Trial Publications
    • The Phase 3 VIKTORIA‑1 trial showed that adding the pan‑PI3K/mTOR inhibitor gedatolisib to fulvestrant, with or without palbociclib, significantly reduced the risk of progression or death in HR+/HER2‑, PIK3CA wild‑type advanced breast cancer previously treated with a CDK4/6 inhibitor, with a manageable safety profile.
    • A randomized Phase 2 neoadjuvant study in ER+/HER2‑ breast cancer demonstrated comparable 12‑week objective radiologic response for palbociclib plus endocrine therapy versus chemotherapy and validated a 31‑gene CDKPredX signature that identifies patients likely chemo‑resistant yet responsive to the palbociclib–endocrine combination.
  • Key Conference Updates
    • At AACR 2026, breast oncology highlights included next‑wave ADC engineering (dual‑payload, immunostimulatory iADCs, and bispecific constructs) with PLK1 inhibition reversing T‑DXd resistance in HER2‑low models, alongside endocrine–epigenetic convergence where palazestrant synergized with KAT6 inhibition, the selective KAT6A degrader PRT13722 achieved durable preclinical regressions with improved hematologic safety, and the kinesin degrader BBI‑940 advanced in KOMODO‑1 for ER+/HER2‑ and TNBC‑LAR.
    • Radiopharm Theranostics reported first‑in‑human 177Lu‑RAD202 demonstrating meaningful tumor uptake at 30 mCi with favorable safety and DSMC‑cleared escalation to 130 mCi in HEAT, and institutions presented early‑setting analyses on pCR under NAC/NACI in ER‑low/HER2‑ disease and real‑world adjuvant capecitabine dose intensity in TNBC with residual disease.
  • Emerging Themes & Macro-Trends
    • Regulatory and policy signals point to growing importance of companion‑diagnostic and dosimetry frameworks for ADCs/iADCs and radiotheranostics, while endocrine–epigenetic combinations may necessitate co‑development biomarker strategies.
    • Strategic priorities articulated in April 2026 emphasize ADC life‑cycle management in HER2‑low/TROP2/PTK7 segments, investment in epigenetic degrader partnerships and ecDNA biomarker assays, and planning radioligand therapy combinations contingent on determination of RAD202’s RP2D.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-04-01 and 2026-04-30 about breast cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Olema Oncology announced new preclinical data at AACR 2026 and reiterated key regulatory milestones for its ER+/HER2- programs: palazestrant (OP-1250) has U.S. FDA Fast Track designation, and OP-3136’s IND was previously cleared with patients enrolling in an ongoing Phase 1 study. The company also highlighted ongoing pivotal Phase 3 trials (OPERA-01/02) in advanced breast cancer. (globenewswire.com) ¹ (read more)
  • Prelude Therapeutics presented preclinical data for PRT13722, an oral, selective KAT6A degrader being developed for HR+/HER2- breast cancer, and said it remains on track to file an IND by mid‑2026 with first‑in‑human studies planned for 2H 2026. The update provides a clear IND timeline tied to advancing this first‑in‑class breast cancer program. (globenewswire.com) ² (read more)
  • Boundless Bio reported at AACR 2026 that its oral kinesin degrader BBI‑940 is in the Phase 1 KOMODO‑1 trial for ER+/HER2‑ and TNBC‑LAR breast cancers and noted the FDA accepted its IND in January 2026. The company framed BBI‑940’s IND status and ongoing first‑in‑human evaluation as part of its ecDNA‑directed therapy strategy. (rttnews.com) ³ (read more)
  • Olema Oncology said it will present initial clinical data for OP‑3136 at ASCO 2026 and again emphasized regulatory status across its breast cancer pipeline: palazestrant holds FDA Fast Track designation and OP‑3136 entered Phase 1 after IND clearance in December 2024. The update underscores multiple ongoing, IND‑enabled trials in ER+/HER2‑ disease. (globenewswire.com) ⁴ (read more)
  • Mabwell initiated a Phase 3 trial of its Nectin‑4–targeting ADC 9MW2821 in triple‑negative breast cancer and disclosed the program has FDA Fast Track designation for Nectin‑4–positive TNBC. The company positioned Fast Track as supportive of expedited development while advancing this pivotal study. (prnewswire.com) ⁵ (read more)
  • FDA posted its ODAC meeting announcement for April 30, 2026, confirming the morning session would review AstraZeneca’s NDA 220359 for camizestrant plus a CDK4/6 inhibitor in HR+/HER2‑ advanced breast cancer with emergent ESR1 mutation detected during first‑line endocrine therapy. The notice detailed the proposed indication and meeting agenda. (fda.gov) ⁶ (read more)
  • On April 30, 2026, the FDA’s ODAC voted 6–3 against the benefit‑risk profile for AstraZeneca’s camizestrant plus a CDK4/6 inhibitor in the proposed first‑line, ESR1‑mutation–guided HR+/HER2‑ advanced breast cancer setting. The panel concluded the data did not demonstrate a clinically meaningful benefit for the NDA. (fiercebiotech.com) ⁷ (read more)
  • Telomir Pharmaceuticals reported FDA clearance of its IND for Telomir‑Zn in advanced or metastatic triple‑negative breast cancer, enabling initiation of a first‑in‑human Phase 1/2 study. The company plans to begin clinical evaluation in 1H 2026. (nasdaq.com) ⁸ (read more)
Conference
Major Conference Updates
Conference Information
  • American Association for Cancer Research (AACR) Annual Meeting 2026; San Diego Convention Center, San Diego, California; April 17–22, 2026.
  • Overall sentiment: Breast oncology content centered on resistance-busting ADC engineering, endocrine-plus-epigenetic convergence, and first radiotheranostic signals in HER2+ disease—foreshadowing combination-heavy and biomarker-driven strategies. (read more)
  • Theme 1: Next‑Wave ADCs and Resistance‑Busting Combinations
    • Significance: ADC innovation remained the dominant translational thread, aiming to deepen responses, overcome HER2‑low resistance, and widen targetable populations. (read more)
    • Mechanism insights / clinical impact: Dual‑payload constructs (e.g., STRO‑227, PTK7 DAR10 [8 exatecan + 2 MMAE]) and HER2 dual‑payload concepts, plus immunostimulatory iADCs (ASP2998 with a STING agonist) seek potency without excess toxicity; PLK1 inhibition (onvansertib) enhanced T‑DXd activity and reversed resistance preclinically in HER2‑low models. Bispecific ADCs (e.g., GenSci139 EGFR×HER2; GS24‑B057 Nectin‑4×TROP2) emphasize internalization and bystander effects. (read more)
    • Patient populations affected: HER2‑low and HER2‑expressing breast cancers; TNBC models; PTK7/TROP2/TF‑positive solid tumors with breast cohorts anticipated as programs enter/advance early trials. (read more)
  • Theme 2: Endocrine–Epigenetic Convergence and ecDNA‑Directed Degradation in ER+ Disease
    • Significance: Multiple presentations converged on deeper ER pathway shutdown and novel chromosomal‑instability biology to delay/overcome acquired resistance. (read more)
    • Mechanism insights / clinical impact: Palazestrant (CERAN/SERD) fully recruits NCoR1 and synergizes with KAT6 inhibition (OP‑3136); the selective KAT6A degrader PRT13722 produced durable complete regressions in HR+/HER2‑ models with improved preclinical hematologic safety; BBI‑940, a selective kinesin degrader, targets ecDNA segregation, with activity in ER+/HER2‑ and TNBC‑LAR models and ongoing KOMODO‑1. (read more)
    • Patient populations affected: ER+/HER2‑ metastatic breast cancer (including ESR1‑mutant); ecDNA+/FGFR1+ subsets; TNBC‑LAR—supporting biomarker‑selected development paths. (read more)
  • Theme 3: HER2‑Targeted Radiotherapeutics Move Forward
    • Significance: First‑in‑human radiotheranostics entered the breast arena, offering receptor‑density‑agnostic cytotoxicity and potential to address heterogeneity. (read more)
    • Mechanism insights / clinical impact: 177Lu‑RAD202 (sdAb to HER2) showed meaningful tumor uptake at 30 mCi and favorable safety; DSMC cleared escalation to 130 mCi in HEAT (NCT06824155), supporting therapeutic‑dose exploration. (read more)
    • Patient populations affected: Heavily pretreated HER2‑positive breast cancer within a pan‑HER2 solid tumor program. (read more)
  • Theme 4: Early‑Setting Optimization in ER‑Low/TNBC
    • Significance: Institutions highlighted neoadjuvant/adjuvant refinements—treatment intensity and histology‑specific responsiveness—signaling interest in risk‑adapted early care. (read more)
    • Mechanism insights / clinical impact: Posters examined pCR by histology under NAC and chemo‑immunotherapy (NACI) in ER‑low/HER2‑ disease, and real‑world relative dose intensity of adjuvant capecitabine for TNBC with residual disease—inputs for trial design and potential guideline nuance. (read more)
    • Patient populations affected: Early‑stage ER‑low/HER2‑negative and TNBC with residual disease post‑neoadjuvant therapy. (read more)
  • Significance
    • Expected clinical or translational readouts: STRO‑004 Phase 1 initial results mid‑2026; PRT13722 IND mid‑2026 with 2H26 FIH; KOMODO‑1 enrolling; HEAT dose escalation to 130 mCi; palazestrant OPERA‑01 top‑line targeted for fall 2026. (read more)
    • Regulatory or policy implications: ADC/iADC and radiotheranostic traction points toward companion‑diagnostic and dosimetry frameworks; endocrine–epigenetic combos may spur co‑development biomarker strategies. (read more)
    • Potential shifts in standard of care: If resistance‑overcoming ADC combinations translate clinically and CERAN/KAT6 approaches deliver durable benefit, HER2‑low and post‑CDK4/6 ER+ settings are poised for change. (read more)
    • Strategic implications: Prioritize HER2‑low/TROP2/PTK7 segments for ADC life‑cycle management; invest in epigenetic degrader partnerships and ecDNA biomarker assays; evaluate RLT combinations once RAD202 RP2D defined. (read more)
Publications Related to Approved Drugs
Phase 3
pertuzumab, pertuzumab, trastuzumab, and hyaluronidase-zzxf
The benefit of adjuvant pertuzumab and trastuzumab according to estrogen receptor and HER2 expression: a Sub-analysis of the APHINITY trial. An exploratory sub-analysis of the phase III APHINITY trial demonstrates that the addition of pertuzumab to adjuvant trastuzumab and chemotherapy yields the most substantial invasive disease-free survival benefit in patients with HER2 FISH-low/ER-positive early breast cancer. These findings highlight the potential for biomarker-guided strategies to optimize patient selection for dual HER2-targeted therapies, warranting further prospective validation. ()
Phase 3
capivasertib
Cost-effectiveness analysis of capivasertib plus fulvestrant in the <i>PIK3CA/AKT1/PTEN</i>-altered subgroup with HR+/HER2- advanced breast cancer: a United States payer perspective. A recent analysis reveals that while capivasertib plus fulvestrant improves quality-adjusted life-years in patients with PIK3CA/AKT1/PTEN-altered HR+/HER2- advanced breast cancer, it is not currently cost-effective from a U.S. payer perspective at its present wholesale acquisition cost. Strategic pricing adjustments or value-based contracting may be required to meet standard willingness-to-pay thresholds and enhance broader market access. ()
New Publications Related to Drugs in Clinical Trial Development
N/A
18F-Fluorodeoxyglucose Positron Emission Tomography for Estimating Outcomes After Initial Treatment for Metastatic Breast Cancer: A Nonrandomized Clinical Cohort Trial. Early 18F-FDG-PET imaging after just two weeks of first-line systemic therapy in newly diagnosed metastatic breast cancer can effectively identify patients with distinct long-term outcomes, improving upon standard CT assessment. Incorporating this early metabolic evaluation offers a valuable strategy to optimize treatment decisions and better estimate progression-free and overall survival. ()
Phase 3
Overall Survival With First-Line vs Second-Line CDK4/6 Inhibitor Use in Advanced Breast Cancer: A Randomized Clinical Trial. In hormone receptor-positive, ERBB2-negative advanced breast cancer, first-line use of CDK4/6 inhibitors did not improve overall survival compared to second-line use but was associated with increased treatment-related toxicities. However, a post hoc analysis suggests a potential overall survival benefit with first-line use specifically in premenopausal patients, highlighting the need for tailored treatment sequencing. ()
Phase 2
Elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma: a randomized controlled phase 2 trial. The addition of the GSK-3β inhibitor elraglusib to gemcitabine and nab-paclitaxel significantly improved median overall survival and 1-year survival rates in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. These findings support the clinical activity of this combination as a first-line treatment and provide a biological rationale for advancing to phase 3 trials. ()
Phase 3
Imlunestrant with or without abemaciclib in advanced breast cancer: safety analyses from the EMBER-3 trial. Imlunestrant, both as a monotherapy and in combination with abemaciclib, demonstrated a favorable and manageable safety profile in patients with ER+, HER2- advanced breast cancer who experienced recurrence or progression on prior endocrine therapy. The treatment-emergent adverse events were generally reversible, low grade, and occurred early, supporting the use of these effective oral therapies. ()
PHASE1, PHASE2
Efficacy of selpercatinib as a first-line treatment for <i>RET</i>-fusion positive non-small-cell lung cancer: a novel two-stage Bayesian network meta-analysis. A novel two-stage Bayesian network meta-analysis incorporating single-arm trial data demonstrated that selpercatinib significantly improves progression-free and overall survival compared to standard chemotherapy regimens in first-line RET-fusion positive non-small-cell lung cancer. This approach enables earlier assessment of single-arm trials, providing payers and decision-makers with greater confidence in anticipated treatment effects. ()
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 previously treated with a CDK4/6 inhibitor. This triplet or doublet therapy offers a compelling new strategy with a manageable safety profile for overcoming resistance in this patient population. ()
Phase 2
Baseline tumor burden and outcomes in patients with rare cancers treated with immunotherapy (Southwest Oncology Group trial S1609). In a large basket trial of rare cancers treated with dual immune checkpoint inhibitors, a larger baseline tumor burden was independently associated with worse overall survival, but not progression-free survival. However, baseline tumor burden was not predictive of tumor regression, suggesting it should be considered a prognostic rather than a predictive factor in this setting. ()
Phase 2
Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial. In the neoadjuvant setting for ER+/HER2- breast cancer, palbociclib plus endocrine therapy showed comparable 12-week objective radiologic response rates to chemotherapy. Furthermore, a novel 31-gene predictive signature (CDKPredX) was developed and validated to identify patients who are resistant to chemotherapy but likely to respond to the palbociclib and endocrine therapy combination. ()
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 is designed to evaluate the efficacy of adding the transient CDK4/6 inhibitor trilaciclib to pembrolizumab and chemotherapy in patients with advanced triple-negative breast cancer. This strategy aims to enhance and prolong the antitumor immune responses induced by the combination of cytotoxic therapy and immune checkpoint inhibition. ()
Phase 2
Post-Hoc Analysis of the Phase II DESTINY-PanTumor02 Study: Local and Central HER2 IHC Concordance and Trastuzumab Deruxtecan Efficacy by HER2 IHC Status in HER2-Expressing Solid Tumors. A post-hoc analysis of the DESTINY-PanTumor02 study revealed only moderate concordance between local and central HER2 immunohistochemistry testing across various solid tumors. These findings underscore the critical need for validated diagnostic tests and standardized algorithms to accurately identify patients who may benefit from HER2-directed therapies like trastuzumab deruxtecan. ()
Phase 3
Clinical and Molecular Evaluation of HER2-Low and Ultralow Breast Cancer in the PENELOPE-B Clinical Trial Cohort. Evaluation of residual tumors from the PENELOPE-B trial characterized HER2-low breast cancer as a distinct molecular phenotype with significantly increased HER2 mRNA expression compared to HER2-zero tumors. In contrast, HER2-ultralow tumors did not exhibit a defined molecular phenotype, highlighting the need for additional biomarkers beyond HER2 to refine eligibility for trastuzumab deruxtecan therapy. ()
Phase 2
Patient-reported outcomes from the randomized ALICE trial evaluating the addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer. The addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer not only improved progression-free survival but also significantly enhanced patient-reported quality of life, emotional well-being, and symptom control. These findings support the continued development of this combination regimen and suggest that baseline quality of life may serve as a predictor of immunotherapy benefit. ()
Phase 3
Transfer Learning and Machine Learning for Training Five-Year Survival Prognostic Models in Early Breast Cancer: Development and Validation Study. Advanced machine learning techniques, including transfer learning and stacked ensembles, significantly improved the calibration of 5-year survival prognostication in early breast cancer compared to the pretrained PREDICT v3 model, particularly when handling missing clinical data. These robust modeling approaches offer the potential for more accurate and reliable survival estimation to guide personalized breast cancer care. ()
Phase 3
Identifying premenopausal patients with early-stage hormone receptor-positive breast cancer at minimal risk of distant recurrence by breast cancer index. An adjusted Breast Cancer Index model successfully identified a subset of premenopausal patients with early-stage, hormone receptor-positive, node-negative breast cancer who have a minimal risk (<5%) of distant recurrence within 10 years. This prognostic tool provides critical information to help personalize and potentially de-escalate adjuvant endocrine therapy in this specific patient population. ()
N/A
COVID-19-Related Financial Hardship and Adherence to Adjuvant Endocrine Therapy Among Women With Early-Stage Breast Cancer. A study of women with early-stage breast cancer revealed that COVID-19-related financial hardships were significantly associated with lower adherence to adjuvant endocrine therapy. These findings emphasize the critical need for routine financial toxicity screening and targeted support interventions to ensure optimal treatment adherence and long-term outcomes. ()
Phase 3
Pembrolizumab for Early-Stage Triple-Negative Breast Cancer: KEYNOTE-522 Japan Subgroup Analysis. A subgroup analysis of the KEYNOTE-522 trial in Japanese patients with high-risk early-stage triple-negative breast cancer confirmed that neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab improved pathologic complete response and event-free survival. The regimen demonstrated a manageable safety profile, supporting its use as a standard of care in this specific population. ()
Phase 1
Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients. A population pharmacokinetic-receptor occupancy model successfully integrated preclinical and clinical data to predict the human pharmacokinetics and target engagement of TAK-500, a novel anti-CCR2 antibody-drug conjugate. This quantitative framework provides a crucial foundation for guiding first-in-human dose selection and optimizing the clinical development of immune cell-directed ADCs. ()
Phase 2
The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study. In a randomized trial of breast cancer patients receiving weekly paclitaxel, the daily administration of the angiotensin-II-receptor blocker losartan significantly reduced the incidence and delayed the onset of grade 2 or higher peripheral neuropathy. Losartan also improved patient-reported quality of life and pain scores without adding toxicity, supporting its potential as a low-cost prophylactic strategy. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast cancer updated from 2026-04-01 to 2026-04-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation---1--1
Not Yet Recruiting5310210131
Recruiting5932702271191
Available-------
Approved for Marketing-------
Active, Not Recruiting2611372314111
Completed-14-1-6
Total90471217696340
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: Dendritic Cell Vaccine NCT05809752 RECRUITING A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) 2026-03
LY3410738, Cisplatin, Gemcitabine, Durvalumab NCT04521686 ACTIVE_NOT_RECRUITING A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations 2026-05
BET Bromodomain Inhibitor ZEN-3694, Abemaciclib NCT05372640 RECRUITING A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors 2026-06-01
: Two Component Product CLBR001 + ABBV-461 NCT06878248 ACTIVE_NOT_RECRUITING A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Combination of CLBR001, an Engineered Autologous T Cell Product, and ABBV-461, an Antibody-Based Biologic, in Subjects With Locally Advanced or Metastatic Breast Cancer 2026-06
Cisplatin, Elimusertib, Gemcitabine Hydrochloride NCT04491942 ACTIVE_NOT_RECRUITING A Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma 2026-06-30
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Paclitaxel NCT07307911 COMPLETED Neuroprotective Effects of Coenzyme Q10 in Paclitaxel-Induced Peripheral Neuropathy 2026-02-10
Letrozole, Fulvestrant, Palbociclib NCT03633331 COMPLETED A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer 2026-02-27
Nab paclitaxel, Epirubicin, Cyclophosphamide, Carboplatin, Sintilimab, Anlotinib NCT04877821 COMPLETED An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer（NeoSACT） 2026-03-10
Fuzaparib NCT07162051 COMPLETED A Single-arm, Open-label Study of Fluzoparib Combination With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer 2026-03-15
TRASTUZUMAB, ATEZOLIZUMAB, PERTUZUMAB NCT03417544 ACTIVE_NOT_RECRUITING A Phase II Study of Atezolizumab in Combination With Pertuzumab Plus High-dose Trastuzumab for the Treatment of Central Nervous System Metastases in Patients With Her2-positive Breast Cancer 2026-05
Irinotecan, Gemcitabine - 28 day cycle, Lomustine, 9-ING-41, Carboplatin., Paclitaxel., Doxorubicin., Gemcitabine - 21 day cycle, Nab paclitaxel. NCT03678883 ACTIVE_NOT_RECRUITING Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors 2026-06
Paclitaxel NCT04090398 ACTIVE_NOT_RECRUITING Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer 2026-06-30
F-18 16 Alpha-Fluoroestradiol NCT02398773 ACTIVE_NOT_RECRUITING [18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer 2026-06-30
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Paclitaxel + bevacizumab + atezolizumab, Paclitaxel + bevacizumab therapy NCT04732598 COMPLETED A Phase III, Randomized Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer 2026-03-13
Eribulin, Vinorelbine, BL-B01D1, Capecitabine, Gemcitabine NCT06343948 ACTIVE_NOT_RECRUITING A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy 2026-05
Eribulin, Vinorelbine, BL-B01D1, Capecitabine, Gemcitabine NCT06382142 ACTIVE_NOT_RECRUITING A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer After Taxane Failure 2026-06
Exemestane, Goserelin Acetate, Goserelin, Entinostat NCT02115282 ACTIVE_NOT_RECRUITING A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced Breast Cancer 2026-06-02
Fulvestrant, Capivasertib NCT04305496 ACTIVE_NOT_RECRUITING A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor 2026-06-22
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Bone modifying agent NCT04549207 ACTIVE_NOT_RECRUITING A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer (REaCT-Hold BMA) 2026-06
NOTICE: This communication may contain confidential or proprietary information of Oncology Reference, Inc. Data is compiled from publicly available and third-party sources and integrated with proprietary Oncology Reference database mappings, developed and maintained by PhD scientists and advanced AI systems, for organization and analysis. While reasonable efforts are made to ensure accuracy and timeliness, Oncology Reference, Inc. makes no representation or warranty, express or implied, regarding accuracy, completeness, or fitness for a particular purpose. Information may contain errors, omissions, or be subject to change without notice. This material is for informational purposes only and is not medical advice, regulatory guidance, investment advice, or a substitute for professional judgment. Users must independently verify all information.

Oncology Reference, Inc. and its affiliates disclaim all liability for any loss or damage arising from use of or reliance on this information. By using this information, you agree that disputes will be governed by Delaware law and resolved by binding arbitration in Delaware.
California residents waive California Civil Code § 1542. All trademarks are the property of their respective owners.
© 2025 Oncology Reference, Inc. All rights reserved.

CONFIDENTIALITY NOTICE: If you are not the intended recipient, please notify the sender, delete this message, and refrain from using or disclosing its contents.