Clinical Trials for Breast Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced 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: This trial enrolls adults with advanced or metastatic cancers—specifically HR+/HER2- breast cancer resistant to prior CDK4/6 inhibitors, platinum-resistant/refractory ovarian cancers with CCNE1 amplification, and other CCNE1-amplified solid tumors—treating them with INX-315, an oral selective CDK2 inhibitor, as monotherapy or in combination with fulvestrant and abemaciclib. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT05735080

A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative 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: This trial enrolls adults with unresectable locally advanced or metastatic triple-negative breast cancer—including those with stable CNS metastases—to receive a combination of the BET bromodomain inhibitor ZEN003694 (targets epigenetic regulation), pembrolizumab, and nab-paclitaxel. Dose escalation includes any prior therapy and PD-L1 status, while expansion focuses on PD-L1–negative patients with limited prior lines and biopsy-accessible disease.

ClinicalTrials.gov ID: NCT05422794

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted 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 advanced or metastatic solid tumors harboring homozygous MTAP deletions who have progressed on standard therapy are eligible for treatment with TNG462, a selective PRMT5 inhibitor targeting MTAP-deleted tumor cells, either as monotherapy or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05732831

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative 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: This trial enrolls adults with relapsed or refractory triple-negative breast cancer (TNBC) and tests autologous iC9-CAR.B7-H3 T cell therapy, a CAR-T product targeting the B7-H3 antigen with an inducible caspase 9 safety switch, after lymphodepleting chemotherapy. Patients with symptomatic CNS metastases or other interfering cancers are excluded.

ClinicalTrials.gov ID: NCT06347068

Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer

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 women aged 60 or older, or younger but frail, with unresectable locally advanced or metastatic HR+ HER2-negative or triple negative breast cancer who have progressed on at least one prior systemic therapy, and treats them with low-dose capecitabine (1000 mg orally once daily), a prodrug of 5-fluorouracil. The study is focused on balancing efficacy and tolerability in this higher-risk population.

ClinicalTrials.gov ID: NCT06105684

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents 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: This trial is enrolling adults with advanced, unresectable, or metastatic solid tumors harboring PIK3CA (PI3Kα) mutations, including HR+ breast, gynecologic, endometrial, and head and neck cancers, to receive the investigational orally administered mutant-selective PI3Kα inhibitor STX-478 as monotherapy or in combination with standard endocrine and CDK4/6 inhibitors. Eligible patients must have ECOG 0-1 and adequate organ function; those with uncontrolled diabetes or symptomatic CNS metastases are excluded.

ClinicalTrials.gov ID: NCT05768139

Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This trial enrolls adults with measurable, recurrent, unresectable, or metastatic NECTIN4-amplified breast cancer (either HR+/HER2-negative or triple-negative) who have received up to three prior lines of therapy. All participants receive zelenectide pevedotin (BT8009), a NECTIN4-targeting Bicycle Toxin Conjugate delivering MMAE.

ClinicalTrials.gov ID: NCT06840483

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

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: This trial enrolls adults with either HER2-positive metastatic breast cancer that has progressed after prior therapy including T-DXd, or RAS/BRAF wild-type, pMMR/MSS metastatic colorectal cancer that has progressed after oxaliplatin-based first-line therapy, to receive the investigational CD47-blocking fusion protein evorpacept (which enhances macrophage-mediated phagocytosis) in combination with trastuzumab plus chemotherapy or with cetuximab and FOLFIRI, respectively. Candidates must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT07007559

A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/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: Eligible adult patients with advanced, relapsed, or treatment-refractory solid tumors—including specific expansion cohorts for breast, pancreatic, ovarian, or colorectal cancer—may receive SON-DP, a first-in-class investigational protein that reprograms malignant cells into normal tissue cells rather than killing them, via IV infusion.

ClinicalTrials.gov ID: NCT05989724

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected 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: Eligible patients are adult women with ER-positive, HER2-negative advanced breast cancer previously treated with CDK4/6 inhibitors or with metastatic high-grade serous ovarian cancer previously treated with platinum-based chemotherapy. The trial investigates AZD8421, an oral CDK2 inhibitor, as monotherapy or in combination with either camizestrant (oral SERD) or a CDK4/6 inhibitor.

ClinicalTrials.gov ID: NCT06188520