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Breast cancerFebruary 2026
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Breast-Cancer — Monthly Compass
Feb 01–28, 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
  • Practice-Changing Updates
    • Adjuvant abemaciclib plus endocrine therapy achieved a statistically significant overall survival benefit (HR 0.842) with sustained IDFS and DRFS at a 76.2‑month median follow‑up in high‑risk HR‑positive, HER2‑negative, node‑positive early breast cancer without new delayed toxicity concerns.
  • Important Drug Publication Updates
    • In DESTINY‑Breast05, adjuvant trastuzumab deruxtecan significantly improved invasive disease‑free survival versus trastuzumab emtansine in high‑risk HER2‑positive early breast cancer with residual disease post‑neoadjuvant therapy, albeit with a higher incidence of interstitial lung disease necessitating careful monitoring.
  • Key Clinical Development Updates
    • FDA accepted and granted Priority Review to the sBLA for DATROWAY (datopotamab deruxtecan‑dlnk) as first‑line therapy for unresectable/metastatic TNBC in patients ineligible for PD‑1/PD‑L1 inhibitors, with a June 2, 2026 PDUFA target supported by TROPION‑Breast02 showing a statistically significant overall survival advantage and a 43% reduction in risk of progression or death versus chemotherapy.
    • Additional pipeline momentum includes FDA acceptance of Roche’s NDA for giredestrant plus everolimus in ESR1‑mutated ER+/HER2− disease with a December 18, 2026 PDUFA date, ongoing FDA review of Arvinas’ vepdegestrant with a June 5, 2026 PDUFA and Fast Track status, and FDA Fast Track designation for Artios’ Polθ inhibitor ART6043 with olaparib with a global randomized phase 2 launch in gBRCA‑mutated HER2‑negative breast cancer.
  • Important Clinical Trial Publications
    • The Phase 3 SONIA trial found no overall survival advantage for first‑line versus second‑line CDK4/6 inhibitor use in HR‑positive, HER2‑negative advanced breast cancer, with increased toxicity and costs for first‑line therapy and a subgroup signal suggesting a first‑line survival benefit in premenopausal women.
    • In TNBC treated with neoadjuvant docetaxel‑carboplatin plus pembrolizumab, stromal TILs and the TNBC‑DX genomic signature independently predicted pCR, and an integrated model identified 40% of patients with pCR rates exceeding 85% to inform escalation or de‑escalation strategies.
  • Key Conference Updates
    • AACR IO titles highlighted LAG‑3 association with poor prognosis and enhanced efficacy when LAG‑3 blockade was added to PD‑1 plus radiation in breast cancer, while spatial single‑cell studies linked tumor‑immune architectures to ctDNA release and prognosis in luminal disease.
    • Greenwich LifeSciences reported acceptance of two AACR 2026 abstracts and ongoing Phase 3 development of Fast Track‑designated GLSI‑100 (GP2) aimed at preventing post‑surgical breast cancer recurrences.
  • Emerging Themes & Macro-Trends
    • ADC platforms are advancing toward earlier‑line use with differentiation via dual‑payload constructs and novel linkers, and emerging antigens such as CEACAM6 are broadening applicability into HER2‑low and TROP2‑rich segments.
    • Selective covalent PI3Kα inhibition exemplified by TOS‑358 with >95% continuous target engagement in PIK3CA‑mutant tumors suggests a credible path to re‑establish PI3K targeting in ER+/HER2− disease and potentially move earlier pending efficacy and tolerability signals.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-02-01 and 2026-02-28 about breast-cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Daiichi Sankyo and AstraZeneca said FDA accepted and granted Priority Review to a supplemental BLA for DATROWAY (datopotamab deruxtecan‑dlnk) as first‑line therapy for unresectable/metastatic TNBC in patients ineligible for PD‑1/PD‑L1 inhibitors; the PDUFA target action date is June 2, 2026. The submission is supported by TROPION‑Breast02 showing a statistically significant overall survival benefit and a 43% reduction in risk of progression or death vs chemotherapy. ¹ (daiichisankyo.us) (read more)
  • Roche announced FDA acceptance of the NDA for giredestrant plus everolimus to treat ER+/HER2−, ESR1‑mutated locally advanced or metastatic breast cancer after prior endocrine therapy, with a PDUFA date of December 18, 2026. The filing is based on the phase III evERA study and, if approved, could be the first oral SERD combination in the post‑CDK4/6 setting. ² (globenewswire.com) (read more)
  • Artios Pharma received FDA Fast Track designation for its DNA polymerase theta (Polθ) inhibitor ART6043 in combination with olaparib for adults with gBRCA‑mutated, HER2‑negative locally advanced or metastatic breast cancer. Artios said it is launching a global randomized phase 2 study in this population. ³ (globenewswire.com) (read more)
  • Arvinas’ Q4 2025 update confirmed the FDA is reviewing the NDA for vepdegestrant (oral PROTAC ER degrader) in ESR1‑mutated ER+/HER2− advanced or metastatic breast cancer, with a PDUFA action date of June 5, 2026. The company also reiterated that vepdegestrant has FDA Fast Track designation. ⁴ (globenewswire.com) (read more)
  • Greenwich LifeSciences announced acceptance of two AACR 2026 abstracts and noted its phase 3 FLAMINGO‑01 trial is evaluating Fast Track‑designated GLSI‑100, an immunotherapy intended to prevent breast cancer recurrences. The corporate update underscores ongoing phase 3 development of GLSI‑100 under Fast Track. ⁵ (investor.greenwichlifesciences.com) (read more)
Conference
Major Conference Updates
Conference Information
  • AACR Immuno-Oncology Conference (AACR IO), JW Marriott Los Angeles L.A. Live, Los Angeles, CA; February 18–21, 2026. RiseUp for Breast Cancer and Women’s Health, Hotel Nikko, San Francisco, CA; February 19–21, 2026. 16th World ADC London Summit, London, UK; February 23–26, 2026. ESMO Targeted Anticancer Therapies (TAT) Congress 2026, Paris, France; March 16–18, 2026. (read more)
  • Overall: February content emphasized prevention/early-interception, IO combinations with radiation and biomarker integration, and next‑gen precision/ADC modalities poised to move earlier in breast-cancer care. (read more)
  • Theme 1: Prevention & Early‑Interception (Vaccines, Endocrine Modulation)
    • Significance: Momentum to reduce incidence and post‑surgical recurrence by shifting treatment upstream, aligning with investor/payer interest in durable risk reduction. (read more)
    • Mechanism insights / clinical impact: HAV-088 (androgen receptor agonist implant) targets hormonally active breast tissue; a pilot randomized trial vs tamoxifen in high‑risk premenopausal women with dense breasts/high MRI BPE underscores mechanism‑driven prevention. GLSI‑100 (GP2) in Phase III “FLAMINGO‑01” seeks to prevent recurrences via HER2‑directed immunotherapy; two AACR 2026 abstracts were accepted. (read more)
    • Patient populations affected: High‑risk premenopausal women (dense breasts, elevated BPE); post‑operative patients at risk of recurrence including those with HER2 expression. (read more)
  • Theme 2: IO Combinations, Radiotherapy Synergy, and Translational Biomarkers
    • Significance: IO beyond PD‑1 alone—alternative checkpoints and RT combinations plus spatial/molecular profiling to refine who benefits, and when. (read more)
    • Mechanism insights / clinical impact: AACR IO titles highlight LAG‑3 association with poor prognosis and enhanced efficacy when LAG‑3 blockade is added to PD‑1 plus radiation in breast cancer; spatial single‑cell studies link tumor‑immune architectures to ctDNA release and prognosis in luminal disease—supporting integrated IO+RT strategies and circulating endpoints. (read more)
    • Patient populations affected: Luminal breast cancer (prognostic ctDNA/architecture work) and broader breast subtypes in settings where RT is part of multimodality care. (read more)
  • Theme 3: Next‑Gen Precision Targeting of PI3Kα Mutations
    • Significance: For ER+/HER2− tumors with PIK3CA mutations, highly selective covalent inhibitors could re‑open the class with deeper pathway suppression. (read more)
    • Mechanism insights / clinical impact: TOS‑358 (covalent pan‑mutant PI3Kα inhibitor) with >95% continuous target engagement; updated Phase 1 monotherapy safety/efficacy (including PI3Kα‑mutant breast cancer with E345/E542/E545/H1047 variants) to be presented at ESMO TAT 2026. (read more)
    • Patient populations affected: ER+/HER2−, PIK3CA‑mutant metastatic cohorts; potential expansion into earlier lines pending efficacy/tolerability signals. (read more)
  • Theme 4: ADC Platforms Advancing Toward Earlier Lines
    • Significance: ADC field is prioritizing differentiation (dual payloads, novel linkers) and progression to earlier‑line use—highly relevant to breast oncology where ADCs are entrenched. (read more)
    • Mechanism insights / clinical impact: London panels spotlight earlier‑line strategies and dual‑payload constructs aimed at overcoming resistance; emerging antigens (e.g., CEACAM6) illustrate pipeline breadth. (read more)
    • Patient populations affected: Metastatic and, prospectively, earlier‑line breast‑cancer segments as platforms generalize to HER2‑low/TROP2‑rich settings and beyond. (read more)
  • Significance
    • Expected clinical or translational readouts: ESMO TAT (March 16, 2026) for TOS‑358; AACR 2026 titles on March 17 and full abstracts on April 17 for GLSI‑100/FLAMINGO‑01. (read more)
    • Regulatory or policy implications: Prevention‑focused trials using imaging/biomarker enrichment may catalyze payer dialogue on coverage for high‑risk interception strategies. (read more)
    • Potential shifts in standard of care: IO+RT combinations and ctDNA‑informed selection could refine adjuvant/radiation paradigms; validated covalent PI3Kα inhibition may reposition PI3K targeting. (aacr.org) (read more)
    • Strategic implications: Prioritize portfolios with prevention (hormonal and vaccine) assets, biomarker‑integrated IO‑RT trials, and selective PI3Kα and ADC platforms that can credibly move earlier in breast‑cancer lines. (read more)
Publications Related to Approved Drugs
Phase 3
abemaciclib
Overall survival with abemaciclib in early breast cancer. Adjuvant abemaciclib combined with endocrine therapy demonstrated a statistically significant overall survival benefit (HR 0.842) and sustained improvements in invasive disease-free and distant relapse-free survival at a median follow-up of 76.2 months in patients with HR-positive, HER2-negative, node-positive, high-risk early breast cancer. These results confirm the long-term clinical efficacy of abemaciclib in the adjuvant setting without new delayed toxicity concerns. ()
New Publications Related to Drugs in Clinical Trial Development
Here are the key publication updates for breast cancer clinical trials from February 1, 2026, to February 28, 2026:
Phase 3
The Effect of Itraconazole on the Pharmacokinetics of Vepdegestrant, a PROteolysis TArgeting Chimera Estrogen Receptor Degrader, in Healthy Adult Participants Coadministration of the PROTAC estrogen receptor degrader vepdegestrant with the strong CYP3A4 inhibitor itraconazole in healthy adults increased vepdegestrant plasma exposure by approximately 69%, indicating a need for potential dose adjustments or monitoring. This pharmacokinetic interaction suggests that CYP3A4-mediated metabolism plays a significant, though not predominant, role in the elimination of vepdegestrant. ()
Phase 2
Stromal tumor infiltrating lymphocytes and TNBC-DX provide complementary prognostic information in triple-negative breast cancer In triple-negative breast cancer patients treated with neoadjuvant docetaxel-carboplatin plus pembrolizumab, stromal tumor-infiltrating lymphocytes (sTILs) and the TNBC-DX genomic signature independently predicted pathologic complete response (pCR). An integrated classification model combining both biomarkers identified a subgroup comprising 40% of patients who achieved a pCR rate exceeding 85%, suggesting utility for guiding chemoimmunotherapy escalation or de-escalation strategies. ()
Phase 2
Precision treatment with artificial intelligence assisted subtyping enhances therapeutic efficacy in HR+/HER2- breast cancer: The LINUXtrial The Phase II LINUX platform trial demonstrated that artificial intelligence-assisted subtyping significantly improved objective response rates in metastatic HR+/HER2- breast cancer patients resistant to CDK4/6 inhibitors when treated with subtyping-based precision therapy compared to physician's choice. Specific subtypes (SNF2 and SNF4) showed marked clinical benefit, highlighting the potential of AI-driven precision medicine to optimize therapeutic selection in this refractory setting. ()
Phase 3
Trastuzumab Deruxtecan in Residual HER2-Positive Early Breast Cancer In the Phase 3 DESTINY-Breast05 trial involving patients with high-risk HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy, adjuvant trastuzumab deruxtecan (T-DXd) significantly improved invasive disease-free survival compared to trastuzumab emtansine (T-DM1). While T-DXd demonstrated superior efficacy, it was associated with a higher incidence of interstitial lung disease, necessitating careful monitoring. ()
Phase 2
Neoadjuvant endocrine therapy with sequential palbociclib and chemotherapy based on Ki67 status in stage II-III breast cancer: An open-label, phase II study The Phase 2 PETREMAC trial demonstrated that a sequential neoadjuvant strategy starting with endocrine therapy and adding palbociclib for patients with insufficient Ki67 reduction is feasible for large or locally advanced ER-positive/HER2-negative breast cancer. This approach allowed a significant proportion of patients to achieve adequate antiproliferative response without chemotherapy, reserving neoadjuvant chemotherapy for non-responders. ()
Phase 3
Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial This study protocol outlines a randomized controlled Phase 3 trial evaluating the efficacy and biological mechanisms of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters in breast cancer patients. The trial aims to determine if electroacupuncture, combined with standard antiemetics, can significantly reduce the incidence and severity of nausea, vomiting, and related symptoms compared to sham intervention. ()
Phase 2
Circulating tumor DNA in neoadjuvant endocrine therapy for early breast cancer A retrospective analysis of the Phase II PELOPS trial found that detecting circulating tumor DNA (ctDNA) prior to neoadjuvant endocrine therapy was associated with higher pathological stage and residual cancer burden. Persistent ctDNA detection before surgery predicted a higher risk of distant recurrence, supporting the utility of ctDNA dynamics as a biomarker for tumor burden and long-term prognosis in early breast cancer. ()
Phase 2
HER2 testing in multiple solid tumor types: concordance of immunohistochemistry scores between three HER2 scoring algorithms An analysis of HER2 immunohistochemistry scoring across multiple solid tumors from the DESTINY-PanTumor02 trial revealed that while concordance between pathologists was high for IHC 3+ and 0 scores, it was lower for IHC 2+ and 1+ cases. These findings underscore the real-world challenge of inter-pathologist variability in HER2 scoring for non-breast/gastric cancers and highlight the need for standardized scoring practices to accurately identify candidates for HER2-directed therapies. ()
Phase 3
Cognitive Impairment and Chemoendocrine vs Endocrine Therapy in Pre- and Postmenopausal Women: A Secondary Analysis of the RxPONDER Randomized Clinical Trial A secondary analysis of the Phase 3 RxPONDER trial revealed that adding chemotherapy to endocrine therapy was associated with greater patient-reported cognitive impairment compared to endocrine therapy alone in both pre- and postmenopausal women with hormone receptor-positive, HER2-negative breast cancer. This negative impact on cognitive function persisted over 36 months of follow-up, emphasizing the need for interventions to address cancer-related cognitive impairment in this population. ()
Phase 2
Clinical validation of a tissue-agnostic genome-wide methylome enrichment assay to monitor response to pembrolizumab In a Phase 2 trial evaluating pembrolizumab across solid tumors, a tissue-agnostic plasma cfDNA methylation assay demonstrated that a decrease in circulating tumor DNA levels from baseline to pre-cycle 3 was significantly associated with improved clinical outcomes, including objective response and progression-free survival. This validates the platform's potential as a non-invasive tool for early monitoring of immunotherapy response without requiring matched tumor tissue. ()
Phase 1
Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1 Results from the SERENA-1 Phase 1 trial indicate that the combination of the next-generation oral SERD camizestrant with the AKT inhibitor capivasertib is well-tolerated and demonstrates encouraging clinical efficacy in pretreated ER-positive, HER2-negative advanced breast cancer. The safety profile was consistent with the individual monotherapies, and the combination achieved a clinical benefit rate of 51.7% in a heavily pretreated population. ()
Phase 1
Phase I study of bevacizumab and temsirolimus combination therapy in advanced malignancies: safety, efficacy, and ovarian cancer expansion A Phase I study evaluating the combination of bevacizumab and temsirolimus in heavily pretreated advanced solid tumors established the maximum tolerated dose and showed a manageable safety profile with modest clinical activity. While the objective response rate was limited overall, the combination demonstrated a clinical benefit rate of 26.8%, with specific activity observed in the ovarian cancer expansion cohort. ()
Phase 3
Afuresertib plus fulvestrant for pretreated HR-positive, HER2-negative, advanced breast cancer: a phase Ib trial This study evaluated the pan-AKT inhibitor afuresertib combined with fulvestrant in patients with pretreated HR-positive, HER2-negative advanced breast cancer, demonstrating a promising objective response rate of 25.8% and a manageable safety profile. The findings suggest that this combination has potential antitumor activity in patients who have progressed on prior therapies, including CDK4/6 inhibitors, supporting further evaluation in randomized trials. ()
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 Phase 2 TRAIN-3 study demonstrated that an MRI-guided strategy to shorten neoadjuvant chemotherapy duration in patients with stage II-III HER2-positive breast cancer who achieve an early complete radiological response resulted in excellent 3-year event-free survival rates exceeding 92%. This personalized approach allowed for a reduction in chemotherapy cycles without compromising oncologic outcomes, potentially minimizing treatment-related toxicity. ()
Phase 2
DART/SWOG/NCI phase II anti-CTLA-4/PD-1 trial: clear cell carcinomas of ovary, endometrium, cervix In the DART Phase II trial cohort focusing on rare gynecologic clear cell carcinomas, the combination of ipilimumab and nivolumab showed durable antitumor activity, particularly in patients with ovarian clear cell carcinoma. The dual checkpoint inhibition yielded an objective response rate of 9.4% and a clinical benefit rate of 21.9%, with some responses lasting over three years, suggesting a potential therapeutic avenue for these aggressive malignancies. ()
PHASE1, PHASE2
Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors A Phase 1 dose-escalation study of rezatapopt, a first-in-class p53 reactivator, demonstrated a manageable safety profile and preliminary antitumor activity in heavily pretreated patients with advanced solid tumors harboring the TP53 Y220C mutation. Confirmed responses were observed across various tumor types, including breast cancer, validating the mechanism of restoring p53 function and establishing a recommended phase 2 dose. ()
Phase 3
Overall Survival With First-Line vs Second-Line CDK4/6 Inhibitor Use in Advanced Breast Cancer: A Randomized Clinical Trial The Phase 3 SONIA trial found that using CDK4/6 inhibitors in the first-line setting for HR-positive, HER2-negative advanced breast cancer did not improve overall survival compared to using them in the second-line setting. However, first-line use was associated with increased toxicity and costs, suggesting that sequencing CDK4/6 inhibitors in the second line may be a preferred strategy for many patients, though a subgroup analysis indicated potential survival benefit for premenopausal women in the first line. ()
N/A
Monitoring cancer-related fatigue and quality of life in breast and prostate cancer patients after primary treatment: a study protocol for the REBECCA trials in Norway The REBECCA project protocol describes a series of clinical trials utilizing real-world data from wearables and online behavior to monitor cancer-related fatigue and quality of life in breast and prostate cancer patients. By integrating digital biomarkers with clinical data, the study aims to improve the detection and management of functional and emotional decline during cancer recovery. ()
Phase 3
Prognostic and predictive performance of PREDICT 2.1, PREDICT v3, and RSClin in node-negative early breast cancer: a TEAM pathology substudy A validation study within the TEAM trial pathology substudy evaluated the prognostic and predictive performance of PREDICT 2.1, PREDICT v3, and RSClin tools in postmenopausal women with node-negative, hormone-positive early breast cancer. While all scores showed moderate discriminatory ability for survival outcomes, they varied significantly in estimating chemotherapy benefit, with RSClin appearing prognostic but not clearly predictive of chemotherapy efficacy in this cohort. ()
Phase 3
Surgical Outcomes After Neoadjuvant Pembrolizumab Plus Chemotherapy for Triple-Negative Breast Cancer: Results from the Randomized, Placebo-Controlled Phase 3 KEYNOTE-522 Study An analysis of the Phase 3 KEYNOTE-522 trial confirmed that adding neoadjuvant pembrolizumab to chemotherapy for early-stage triple-negative breast cancer did not adversely affect surgical outcomes, including the type or timing of surgery. The combination therapy significantly improved pathological complete response rates without increasing the incidence of surgical complications or delaying adjuvant treatment. ()
Early Phase 1
Talimogene laherparepvec and atezolizumab in HER2-negative breast cancer following neoadjuvant chemotherapy: a window-of-opportunity phase II trial (SOLTI-1503 PROMETEO) The Phase II SOLTI-1503 PROMETEO trial demonstrated that preoperative intratumoral injection of talimogene laherparepvec (T-VEC) combined with atezolizumab is safe and induces immune activation in patients with residual HER2-negative breast cancer after neoadjuvant chemotherapy. The strategy resulted in a 26.9% rate of minimal residual disease (RCB-0/I) at surgery, supporting the potential of this chemo-sparing immunotherapy approach for high-risk patients with residual disease. ()
Phase 2
Short-term hormonal modulation with mifepristone does not induce oncogenic changes in the endometrium of BRCA1/2 pathogenic variant carriers A study involving BRCA1/2 mutation carriers demonstrated that short-term exposure to the progesterone receptor antagonist mifepristone induced amenorrhea without causing oncogenic molecular changes in the endometrium. Transcriptomic and DNA methylation analyses showed no increase in epithelial cell proliferation or cancer-associated signatures, providing preliminary safety data for exploring mifepristone as a breast cancer preventive agent in high-risk populations. ()
Phase 2
Palbociclib, Trastuzumab, and Endocrine Therapy in Pretreated HER2-Positive and PAM50 Luminal Advanced Breast Cancer: Randomized Phase II, SOLTI-1303 PATRICIA Trial The Phase II SOLTI-PATRICIA trial (Cohort C) showed that the triplet combination of palbociclib, trastuzumab, and endocrine therapy significantly improved progression-free survival compared to physician's choice of treatment in pretreated patients with HER2-positive, PAM50 luminal advanced breast cancer. This chemotherapy-free regimen demonstrated a manageable safety profile and offers a potential therapeutic strategy for this specific molecular subgroup. ()
PHASE1, PHASE2
Evaluation of trimetazidine in alleviating paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial A randomized controlled trial found that co-administration of trimetazidine with paclitaxel significantly reduced the incidence and severity of chemotherapy-induced peripheral neuropathy in patients with non-metastatic breast cancer. Patients receiving trimetazidine reported better quality of life and showed higher serum nerve growth factor levels, suggesting a neuroprotective effect that warrants further investigation in larger studies. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast-cancer updated from 2026-02-01 to 2026-02-28:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation-------
Not Yet Recruiting9126-6143
Recruiting4136492294161
Available-------
Approved for Marketing-------
Active, Not Recruiting141221-24172
Completed212-4-9
Total6650982636285
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Rosuvastatin, Midazolam, Vorasidenib, Flurbiprofen, Repaglinide, Omeprazole, Bupropion NCT07235748 COMPLETED A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants 2025-12-23
AZD2014, Fulvestrant NCT01597388 COMPLETED A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer 2026-01-13
Fluorouracil, Leucovorin, Zimberelimab, AB598, 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
Pembrolizumab, ASTX660 NCT05082259 RECRUITING ASTEROID:A Phase I Trial of ASTX660 in Combination With Pembrolizumab in Patients With Solid Tumours: Utilizing Triple IAP Blockade as a Strategy to Maximize Immunogenic Cell Death and the Generation of an Efficient Adaptive Immune Response 2026-03-16
SRG-514 NCT06300411 ACTIVE_NOT_RECRUITING A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery 2026-04-10
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab NCT01796197 COMPLETED Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer 2026-01
Paclitaxel NCT07307911 COMPLETED Neuroprotective Effects of Coenzyme Q10 in Paclitaxel-Induced Peripheral Neuropathy 2026-02-10
Nivolumab, Ipilimumab NCT03789110 ACTIVE_NOT_RECRUITING NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer 2026-02-28
Palbociclib, Letrozole, : Pembrolizumab, Fulvestrant NCT02778685 ACTIVE_NOT_RECRUITING Phase II Study of the Combination of Pembrolizumab, Letrozole, and Palbociclib in Postmenopausal Patients With Newly Diagnosed Metastatic Estrogen Receptor Positive Breast Cancer 2026-03-30
Paclitaxel, Ruxolitinib, Cyclophosphamide, Doxorubicin NCT02876302 ACTIVE_NOT_RECRUITING Phase II Study Of Combination Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer 2026-04
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Physician's choice chemotherapy, Olaparib NCT02000622 COMPLETED A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. 2025-12-23
Capecitabine, Lapatinib, Trastuzumab deruxtecan, Trastuzumab NCT03523585 COMPLETED A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 2025-12-23
faslodex dummy, faslodex 500mg, arimidex dummy, arimidex 1mg NCT01602380 COMPLETED A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy. 2026-01-16
Doxorubicin, Trastuzumab IV, Cyclophosphamide, Docetaxel, Pertuzumab and Trastuzumab FDC SC, Pertuzumab IV, Hormone Therapy NCT04024462 COMPLETED A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Patients With HER2-Positive Early Breast Cancer 2026-01-19
Trastuzumab Deruxtecan NCT04739761 ACTIVE_NOT_RECRUITING An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12) 2026-05-26
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: Trastuzumab Deruxtecan, : Trastuzumab NCT05376878 RECRUITING Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan 2026-05-26
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