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Clinical Trials for Breast Cancer

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There are 309 active trials for advanced/metastatic breast cancer.

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309 trials meet filter criteria.

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No known activity More information High burden on patient More information
Sponsor: Eli Lilly and Company (industry) Phase: 1 Start date: July 28, 2025

TrialFetch AI summary: Adults with advanced/metastatic NSCLC, SCLC, endometrial cancer, or triple‑negative breast cancer after standard options receive LY4175408, an investigational PTK7‑targeted antibody–drug conjugate delivering an exatecan (topoisomerase I inhibitor) payload, given IV every 21 days. Requires ECOG 0–1 and measurable disease (for later cohorts); excludes prior PTK7 topoisomerase I ADCs, uncontrolled CNS metastases, significant cardiac disease, ILD/pneumonitis, active infection, and prolonged QTc.

ClinicalTrials.gov ID: NCT07046923

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: 1/2 Start date: July 6, 2023

TrialFetch AI summary: Adults with advanced solid tumors including HNSCC, pancreatic adenocarcinoma, NSCLC, HR+/HER2− breast cancer post‑CDK4/6 inhibitor, or platinum‑resistant high‑grade serous ovarian/related cancers receive the oral CDK7 inhibitor GTAEXS617 (transcription/cell‑cycle regulator) as monotherapy or combined with standard-of-care regimens. Eligible patients have ECOG 0–1 and adequate organ function; study explores safety, PK, and preliminary activity with tumor biopsies required.

ClinicalTrials.gov ID: NCT05985655

No known activity More information High burden on patient More information
Sponsor: Avenzo Therapeutics, Inc. (industry) Phase: 1/2 Start date: Aug. 20, 2025

TrialFetch AI summary: Adults with advanced solid tumors (dose escalation enriched for CDK4/CCND1-amplified tumors) and a phase 2 focus on HR+/HER2- metastatic breast cancer receive AVZO-023, an oral selective CDK4 inhibitor, as monotherapy or combined with AVZO-021 (selective CDK2 inhibitor) and/or endocrine therapy (fulvestrant or letrozole). Prior CDK2/4/6 inhibitor exposure is excluded; endpoints assess safety, PK/PD, and antitumor activity with combination cohorts at RP2D in HR+/HER2- disease.

ClinicalTrials.gov ID: NCT06998407

No known activity More information High burden on patient More information
Sponsor: Normunity AccelCo, Inc. (industry) Phase: 1 Start date: Oct. 30, 2025

TrialFetch AI summary: Adults with refractory locally advanced or metastatic solid tumors limited to NSCLC, TNBC, HNSCC, esophageal (SCC/adenocarcinoma), gastric/GEJ adenocarcinoma, and gynecologic (cervical/endometrial/ovarian) cancers (ECOG 0–1) receive NRM-823, a bispecific T‑cell engager targeting CD3 and a novel tumor antigen, as monotherapy with dose escalation/expansion, with a cohort combining NRM-823 plus an immune checkpoint inhibitor. Primary focus is safety and RP2D determination, with preliminary antitumor activity assessment.

ClinicalTrials.gov ID: NCT07182149

No known activity More information High burden on patient More information
Sponsor: Pfizer (industry) Phase: 1 Start date: Dec. 16, 2025

TrialFetch AI summary: Adults with measurable advanced/metastatic breast cancer (progressed after ≥1 line endocrine therapy and a CDK4/6 inhibitor) or advanced/metastatic colorectal cancer (previously treated per standard options, plus one cohort without prior chemo for metastatic disease), ECOG 0–1. Participants receive oral investigational agent PF-08032562 (target/mechanism not publicly described) as monotherapy or combined with fulvestrant (breast) or cetuximab or FOLFOX + bevacizumab (colorectal) in 28-day cycles with dose escalation/expansion.

ClinicalTrials.gov ID: NCT07318805

No known activity More information High burden on patient More information
Sponsor: BeOne Medicines (industry) Phase: 1 Start date: Dec. 11, 2025

TrialFetch AI summary: Enrolls adults with measurable advanced/metastatic breast cancer (primary focus; postmenopausal or on ovarian suppression, ECOG 0–1) and select other refractory advanced solid tumors; Part 1A includes heavily pretreated patients lacking standard options, while breast cancer expansion cohorts include patients with 1–3 prior metastatic lines or (in certain regions) CDK4/6-inhibitor–naïve and untreated for advanced disease. Tests oral BG-75202, a small-molecule KAT6A/KAT6B lysine acetyltransferase inhibitor, as monotherapy and in combination with endocrine therapy (estrogen receptor antagonist) and with CDK4 inhibition plus an aromatase inhibitor.

ClinicalTrials.gov ID: NCT07222267

No known activity More information High burden on patient More information
Sponsor: Novartis Pharmaceuticals (industry) Phase: 1/2 Start date: Dec. 29, 2025

TrialFetch AI summary: Enrolls adults with advanced malignancies, primarily HR+/HER2− advanced breast cancer that has progressed after endocrine therapy plus a CDK4/6 inhibitor (phase II limited to ≤2 prior endocrine lines for advanced disease and no prior chemotherapy/ADC in the advanced setting), with additional phase I cohorts for CCNE1-amplified solid tumors and metastatic castration-resistant prostate cancer. Patients receive the first-in-human investigational agent GVV858 (target/mechanism not publicly specified) as monotherapy or combined with endocrine therapy—fulvestrant (and letrozole in phase I), with phase II evaluating two GVV858 dose regimens plus fulvestrant.

ClinicalTrials.gov ID: NCT07288359

No known activity More information High burden on patient More information
Sponsor: ProteinQure Inc. (industry) Phase: 1 Start date: Sept. 16, 2025

TrialFetch AI summary: Adults with metastatic or locally advanced solid tumors (including interest in TNBC) that have progressed after or are ineligible for standard therapy, with ECOG 0–1, measurable disease, adequate organ/cardiac function, and no significant cardiac disease/QTc prolongation, active >grade 1 neuropathy, or prior MMAE- or SORT1-targeted therapy. Participants receive PQ203, a once-weekly IV SORT1-targeting peptide–drug conjugate delivering the microtubule inhibitor MMAE to SORT1-expressing tumor cells, in dose-escalation/optimization to establish RP2D and assess preliminary antitumor activity.

ClinicalTrials.gov ID: NCT07190469

No known activity More information High burden on patient More information
Sponsor: Cogent Biosciences, Inc. (industry) Phase: 1 Start date: Dec. 30, 2025

TrialFetch AI summary: Enrolls adults with locally advanced/metastatic/unresectable solid tumors harboring ERBB2 (HER2) activating alterations, NRG1 fusions, or HER2 overexpression, with expansion cohorts for ERBB2-mutant NSCLC with brain metastases and ERBB2-mutant or HER2-overexpressing breast cancer with brain metastases ± leptomeningeal disease. Patients receive oral CGT4255, an investigational EGFR-sparing selective HER2 tyrosine kinase inhibitor designed to cover multiple oncogenic HER2 mutations with CNS penetration, given at escalating/selected doses.

ClinicalTrials.gov ID: NCT07361562

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

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