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Clinical Trials for Breast Cancer

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There are 318 active trials for advanced/metastatic breast cancer.

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318 trials meet filter criteria.

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No known activity More information High burden on patient More information
Sponsor: Astellas Pharma Global Development, Inc. (industry) Phase: 1/2 Start date: Jan. 12, 2026

TrialFetch AI summary: Adults with ECOG 0–1 locally advanced unresectable or metastatic solid tumors (including NSCLC without actionable alterations, urothelial carcinoma, gastric/GEJ cancer, and HER2-negative breast cancer) in selected treatment settings, including 2L+ NSCLC and post–enfortumab vedotin+pembrolizumab urothelial carcinoma, plus first-line metastatic NSCLC (adenocarcinoma) and urothelial cohorts. Patients receive IV ASP2998, a first-in-human TROP2-targeting antibody–drug conjugate, as monotherapy or combined with pembrolizumab and/or carboplatin, and/or with enfortumab vedotin (urothelial cohorts), in 21-day cycles until progression or toxicity.

ClinicalTrials.gov ID: NCT07287995

No known activity More information High burden on patient More information
Sponsor: Boundless Bio, Inc. (industry) Phase: 1 Start date: Feb. 12, 2026

TrialFetch AI summary: For adults with locally advanced or metastatic breast cancer (ECOG 0–1) previously treated with standard subtype-appropriate therapy (including prior endocrine therapy + CDK4/6 inhibitor for ER+/HER2−), enrolling molecularly defined cohorts: ER+/HER2−, ER+/HER2− with FGFR1 amplification, and luminal androgen receptor–subtype TNBC (AR ≥10% by IHC), generally with measurable disease and available tumor tissue. Patients receive oral BBI-940, a first-in-human kinesin molecular degrader designed to disrupt mitotic/ecDNA segregation, as monotherapy or (in ER+/HER2− without ESR1 mutation) in combination with fulvestrant.

ClinicalTrials.gov ID: NCT07408089

No known activity More information High burden on patient More information
Sponsor: Conjupro Biotherapeutics, Inc. (industry) Phase: 1 Start date: Feb. 20, 2026

TrialFetch AI summary: Adults with advanced/unresectable or metastatic solid tumors that have progressed after, are intolerant to, or lack standard systemic options (ECOG 0–1; measurable disease; excluding prior B7-H3–targeted therapy, prior topoisomerase inhibitor ADCs, significant ILD/pneumonitis, uncontrolled infection, or active/untreated CNS metastases). Patients receive SYS6043, an IV q3-week B7-H3 (CD276)–targeted antibody–drug conjugate delivering a cytotoxic payload to B7-H3–expressing tumor cells, with expansion cohorts planned in ES-SCLC, HR+/HER2− breast cancer, mCRPC, and ovarian cancer.

ClinicalTrials.gov ID: NCT07424547

No known activity More information High burden on patient More information
Sponsor: Radiopharm Theranostics, Ltd (industry) Phase: 1/2 Start date: Sept. 24, 2025

TrialFetch AI summary: Enrolls adults with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors (including CRPC, NSCLC/SCLC, CRC, HNSCC, ovarian/cervical/endometrial cancers, TNBC, and esophageal SCC) who have progressed after their most recent therapy and have no suitable standard option, with ECOG 0–2 and adequate organ function (measurable disease required except in CRPC; prior Lu-177–PSMA excluded for CRPC). Patients receive 177Lu-BetaBart, a lutetium-177–labeled anti–B7-H3 (CD276) monoclonal antibody delivering beta-particle radiation as systemic radioimmunotherapy in a dose-escalation/expansion design.

ClinicalTrials.gov ID: NCT07189871

No known activity More information High burden on patient More information
Sponsor: IDEAYA Biosciences (industry) Phase: 1/2 Start date: March 17, 2026

TrialFetch AI summary: Adults with ECOG 0–1 and locally advanced/metastatic solid tumors, including ER+/HER2− breast cancer, NSCLC, CRPC, and MSS colorectal cancer after prior standard therapy, receive oral IDE574 monotherapy; breast cancer cohorts require prior endocrine therapy and CDK4/6 inhibitor. ER+/HER2− breast cancer patients may receive IDE574, an investigational dual KAT6/KAT7 epigenetic inhibitor, in combination with fulvestrant.

ClinicalTrials.gov ID: NCT07540572

No known activity More information High burden on patient More information
Sponsor: Kivu Bioscience Inc. (industry) Phase: 1 Start date: Nov. 13, 2025

TrialFetch AI summary: Adults with locally advanced or metastatic solid tumors refractory to standard therapy or without proven effective options receive KIVU-107, an investigational PTK7-directed antibody-drug conjugate carrying an exatecan/topoisomerase I inhibitor payload. The study includes dose escalation followed by expansion at the recommended dose, with eligibility requiring measurable disease, ECOG 0–1, and adequate organ function.

ClinicalTrials.gov ID: NCT07229313

No known activity More information High burden on patient More information
Sponsor: IDEAYA Biosciences (industry) Phase: 1 Start date: Feb. 24, 2026

TrialFetch AI summary: Adults with ECOG 0–1 and measurable locally advanced/metastatic solid tumors co-expressing B7-H3 and PTK7, after progression/intolerance to prior therapy or lacking standard options, including NSCLC, ESCC, endometrial, ovarian, HNSCC, TNBC, colorectal, and CRPC. All participants receive IDE034, an investigational bispecific B7-H3/PTK7 antibody–drug conjugate with a topoisomerase I inhibitor payload, in dose-escalation and expansion cohorts.

ClinicalTrials.gov ID: NCT07503808

No known activity More information High burden on patient More information
Sponsor: Regor Pharmaceuticals Inc. (industry) Phase: 1 Start date: April 13, 2026

TrialFetch AI summary: Open-label dose-escalation/expansion study of oral RGT-490 monotherapy, a selective mutant PI3Kα inhibitor, in adults with locally advanced unresectable or metastatic solid tumors harboring activating PIK3CA mutations after at least one prior therapy. Expansion focuses on HR+/HER2− advanced breast cancer; patients with prior PI3Kα inhibitor exposure or diabetes requiring antihyperglycemic medication are excluded.

ClinicalTrials.gov ID: NCT07524322

No known activity More information High burden on patient More information
Sponsor: Halda Therapeutics OpCo, Inc. (industry) Phase: 1 Start date: April 13, 2026

TrialFetch AI summary: Enrolling postmenopausal women or women on ovarian suppression with ER+/HER2− metastatic or locally advanced breast cancer, measurable disease, progression after prior metastatic endocrine therapy and prior CDK4/6 inhibitor, and ≤2 prior metastatic chemotherapy regimens. All patients receive oral single-agent HLD-0117, an investigational ER-targeting RIPTAC designed to bind ER and BRD4/essential survival protein to induce proximity-driven tumor-cell death.

ClinicalTrials.gov ID: NCT07524855

No known activity More information High burden on patient More information
Sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. (industry) Phase: 1 Start date: April 8, 2026

TrialFetch AI summary: Adults with ECOG 0–1 and measurable advanced selected solid tumors, including SCLC, extrapulmonary high-grade neuroendocrine/small-cell carcinomas, NSCLC, prostate, ovarian, renal, HNSCC, hepatic, gastric, and triple-negative breast cancers, after progression/relapse/intolerance to at least one standard systemic therapy. All patients receive dose-escalated oral EXS74539/REC-4539 monotherapy, a selective reversible LSD1/KDM1A epigenetic inhibitor, to define safety and MTD with preliminary efficacy assessment.

ClinicalTrials.gov ID: NCT07517198

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