Clinical Trials for Breast Cancer

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Patients with measurable, unresectable locally advanced or metastatic triple-negative or HR-positive/HER2-negative breast cancer that has progressed or recurred receive invikafusp alfa plus sacituzumab govitecan. Invikafusp alfa is an investigational Vβ6/Vβ10 T-cell receptor–targeting, IL-2 receptor–stimulating fusion protein; sacituzumab govitecan is a TROP-2-directed antibody–drug conjugate.

ClinicalTrials.gov ID: NCT06827613

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 advanced solid tumors refractory to standard therapy or lacking a standard option, and ECOG performance status 0–1, receive IV LCB84 alone or with an anti-PD-1 antibody; expansion cohorts focus on selected tumor types. LCB84 is a TROP2-directed antibody–drug conjugate that delivers the cytotoxic payload monomethyl auristatin E.

ClinicalTrials.gov ID: NCT05941507

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)

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.

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: Eligible patients are adults with metastatic or inoperable locally advanced HER2 negative metaplastic breast cancer (including triple negative breast cancer with metaplastic features) who have not previously received nab-paclitaxel or PI3K/AKT/mTOR inhibitors. Treatment consists of nab-paclitaxel plus alpelisib (an oral PI3K-alpha inhibitor) and L-NMMA (a pan-inducible nitric oxide synthase [iNOS] inhibitor), aiming to target chemoresistance pathways in this aggressive subtype.

ClinicalTrials.gov ID: NCT05660083

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.

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.

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: This study enrolls female patients with triple negative, HER2+, or hormone receptor positive breast cancer and asymptomatic, measurable brain metastases, treating them with a personalized anti-HER2/HER3 dendritic cell vaccine (designed to enhance immune targeting of HER2/HER3-expressing cells) combined with the PD-1 inhibitor pembrolizumab. Eligible patients must have ECOG 0-1 and no immediate need for local brain therapy, leptomeningeal disease, or active autoimmune/infectious conditions.

ClinicalTrials.gov ID: NCT04348747

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

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.

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: This trial enrolls adults with HER2-positive breast cancer and confirmed leptomeningeal disease (with or without brain metastases), who will receive radiation therapy followed by intrathecal trastuzumab (HER2-targeted antibody) and dose-escalated intrathecal pertuzumab (HER2 dimerization inhibitor) via an Ommaya reservoir. Patients must have adequate organ function and the ability to undergo Ommaya placement; prior therapies are allowed.

ClinicalTrials.gov ID: NCT04588545

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or metastatic solid tumors receive the investigational oral cyclin E1 degrader BMS-986500 alone, including an expansion cohort with CCNE1-amplified ovarian cancer. Patients with advanced breast cancer previously treated with a CDK4/6 inhibitor may receive BMS-986500 with palbociclib and fulvestrant.

ClinicalTrials.gov ID: NCT06997029

Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy in Participants With Advanced Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 breast, ovarian, or prostate cancer and MRI-confirmed brain metastases receive oral DSB2455, an investigational selective PARP1 inhibitor targeting DNA-damage repair. Eligible patients must have measurable disease, ECOG performance status 0–1, and a safely accessible lesion for biopsy; prior selective PARP1 inhibition is excluded.

ClinicalTrials.gov ID: NCT06458712

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Patients with unresectable locally advanced or metastatic solid tumors harboring eligible AKT/PI3K/PTEN pathway alterations receive the investigational oral selective AKT1 inhibitor TER-2013 alone. Patients with HR-positive/HER2-negative advanced breast cancer previously treated with an aromatase inhibitor may receive TER-2013 with fulvestrant.

ClinicalTrials.gov ID: NCT07109726

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 advanced solid tumors that have progressed after standard therapy or lack a standard treatment option receive a single intravenous infusion of IDOV-Immune. This engineered oncolytic vaccinia virus is designed to replicate preferentially in tumor cells, destroy them, and stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06910657

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, locally advanced unresectable or metastatic FAP-positive solid tumors receive intravenous LY4337713, an investigational lutetium-177 radioligand that targets fibroblast activation protein on cancer-associated fibroblasts to deliver radiation to tumors. Eligible cancers include pancreatic, breast, ovarian, gastric, colorectal, esophageal, and cholangiocarcinoma.

ClinicalTrials.gov ID: NCT07213791