Clinical Trials for Breast Cancer

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic breast cancer are eligible across HER2-positive, HER2-low, HER2-ultralow, HER2-null, and triple-negative cohorts; dose escalation is limited to chemotherapy-pretreated HR-positive, HER2-low or HER2-ultralow disease. Treatment combines BNT323, a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, with BNT327, a PD-L1/VEGF-A bispecific antibody; a randomized cohort also evaluates each drug alone.

ClinicalTrials.gov ID: NCT06827236

Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: This trial enrolls patients aged 65 or older with HR+/HER2- metastatic breast cancer who are eligible for combination endocrine therapy plus either palbociclib or ribociclib (CDK4/6 inhibitors), and randomizes them to receive either standard starting doses or lower, titratable doses of the selected CDK4/6 inhibitor. The goal is to determine which dosing approach better maximizes medication tolerance and reduces early discontinuation in this older population.

ClinicalTrials.gov ID: NCT06377852

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with HR-positive/HER2-negative metastatic breast cancer after at least two prior lines of therapy, including endocrine therapy and a CDK4/6 inhibitor, receive oral BGB-21447, a BCL2 inhibitor, plus fulvestrant, with or without BGB-43395, a selective CDK4 inhibitor. The study evaluates safety, dosing, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT06756932

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated or treatment-refractory unresectable locally advanced or metastatic solid tumors harboring HER2 expression, amplification, or an activating mutation receive intravenous BL-M07D1 every 21 days. BL-M07D1 is a HER2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing cells.

ClinicalTrials.gov ID: NCT06293898

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with ECOG 0–1 and measurable advanced HR+/HER2− breast cancer or selected CCNE1-amplified solid tumors receive oral AVZO-021, an investigational CDK2 inhibitor, alone or in cohort-specific combinations. Combinations include endocrine therapy, CDK4/6 inhibitors, sacituzumab govitecan, or carboplatin; eligibility and prior-treatment requirements vary by cohort.

ClinicalTrials.gov ID: NCT05867251

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1 and selected advanced or metastatic solid tumors receive AZD6750, an investigational CD8-guided IL-2 agent designed to preferentially stimulate CD8-positive T cells. A separate cohort of patients with stage IV NSCLC receives AZD6750 plus rilvegostomig, an investigational PD-1/TIGIT bispecific antibody.

ClinicalTrials.gov ID: NCT07115043

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable recurrent or metastatic triple-negative breast cancer previously treated with a taxane and a topoisomerase inhibitor–payload antibody–drug conjugate are randomized to one of two doses of bulumtatug fuvedotin. This investigational antibody–drug conjugate targets Nectin-4 and delivers the cytotoxic payload monomethyl auristatin E (MMAE); there is no standard-treatment control arm.

ClinicalTrials.gov ID: NCT06908928

A Phase 1b/2, Open-Label, Multicohort Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated, unresectable locally advanced or metastatic HER2-positive, HER2-low, or HER2-ultralow breast cancer receive disitamab vedotin monotherapy every 2 weeks; prior trastuzumab deruxtecan is required for the HER2-positive and HR-positive/HER2-low cohorts. Disitamab vedotin is a HER2-directed antibody–drug conjugate that delivers the microtubule inhibitor monomethyl auristatin E.

ClinicalTrials.gov ID: NCT06966453

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with locally advanced or metastatic ER-positive, HER2-negative breast cancer that progressed on or after CDK4/6 inhibitor and endocrine therapy, and who have not received chemotherapy for metastatic disease, receive investigational GDC-4198 alone or with giredestrant in dose finding. The randomized comparison tests two doses of GDC-4198, a CDK4/CDK2 inhibitor, plus giredestrant, an oral estrogen receptor degrader, against abemaciclib plus giredestrant.

ClinicalTrials.gov ID: NCT07100106

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced solid tumors that have progressed after at least one systemic therapy receive FT836, an off-the-shelf, induced pluripotent stem cell–derived CAR T-cell therapy targeting MICA/MICB. FT836 is given alone or with paclitaxel, cetuximab, or trastuzumab, including paclitaxel–antibody combinations.

ClinicalTrials.gov ID: NCT07216105