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: This trial enrolls adults with unresectable, locally advanced, or metastatic solid tumors—specifically metastatic triple-negative or HR+/HER2- breast cancer after progression—testing the combination of sacituzumab govitecan and Invikafusp alfa (STAR0602), a novel bispecific antibody that targets and activates Vβ6/Vβ10 TCR-expressing T cells to enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT06827613

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-559, an Oral Inhibitor of the Helicase DHX9, in Patients With Locally Advanced or Metastatic Solid Tumors and Molecularly Defined Cancers

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: This trial enrolls adults with locally advanced or metastatic solid tumors refractory to standard therapies, with expansion cohorts for BRCA1/2-deficient, HER2-negative metastatic breast cancer and unresectable/metastatic dMMR or MSI-H tumors, to evaluate the safety and early efficacy of ATX-559, a first-in-class oral DHX9 helicase inhibitor.

ClinicalTrials.gov ID: NCT06625515

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: Eligible patients are adults with advanced, refractory solid tumors of any histology (including those with stable, treated CNS metastases) and good performance status. The trial evaluates LCB84, a TROP2-targeted antibody-drug conjugate delivering MMAE, given alone or in combination with an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05941507

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

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: This trial enrolls adults with advanced or metastatic solid tumors (including expansion cohorts for triple-negative breast cancer or gastric/gastroesophageal junction cancer) refractory to standard therapies, and patients with relapsed/refractory acute myeloid leukemia, to evaluate the safety and preliminary efficacy of BAL0891, a dual TTK/PLK1 mitotic checkpoint inhibitor, as monotherapy or in combination with carboplatin or paclitaxel.

ClinicalTrials.gov ID: NCT05768932

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

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: Eligible patients are adults with HR+/HER2- metastatic breast cancer who have progressed on at least two prior lines of therapy (including both endocrine therapy and a CDK4/6 inhibitor) and will receive BGB-21447, a selective oral Bcl-2 inhibitor, in combination with fulvestrant with or without the investigational oral CDK4 inhibitor BGB-43395. Both postmenopausal women and men with good performance status and adequate organ function may enroll.

ClinicalTrials.gov ID: NCT06756932

Multicenter Phase I/Ib Trial of Olaparib in Combination with Vorinostat in Patients with Relapsed/Refractory And/or Metastatic 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 trial enrolls adults with relapsed/refractory or metastatic, HER2-negative breast cancer to receive a combination of olaparib (a PARP inhibitor targeting DNA repair) and vorinostat (a histone deacetylase inhibitor) to assess safety, tolerability, and preliminary efficacy. Prior treatment with PARP or HDAC inhibitors is not allowed, and participants require good performance status and adequate organ function.

ClinicalTrials.gov ID: NCT03742245

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 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/Metastatic 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: This trial enrolls adults with unresectable locally advanced or metastatic solid tumors—including colorectal, triple-negative breast, melanoma, and ovarian cancer—who have progressed on or cannot receive standard therapies, to receive NM1F (a PVRIG/CD112R immune checkpoint inhibitor) alone or in combination with pembrolizumab. Key exclusions are active CNS involvement, prior PVRIG/CD226-axis therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT05746897

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 advanced solid tumors receive first-in-human BMS-986500 monotherapy (with a dedicated expansion for CCNE1-amplified ovarian cancer); separate cohorts enroll advanced breast cancer previously treated with a CDK4/6 inhibitor to receive BMS-986500 combined with palbociclib plus fulvestrant. BMS-986500’s molecular target/mechanism is undisclosed; the study focuses on safety/PK and dose finding with exploratory efficacy by RECIST.

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 advanced/metastatic breast, ovarian, or prostate cancer (including patients with known brain metastases), ECOG 0–1, and measurable disease receive oral DSB2455, a PARP1‑selective inhibitor aiming to exploit synthetic lethality in HR‑deficient tumors (e.g., BRCA/HRR alterations); prior first‑line PARP inhibitor exposure is allowed, but prior PARP1‑selective therapy is excluded. Single‑arm dose escalation/expansion evaluates safety and preliminary activity, with CNS penetration highlighted and mandatory biopsies required.

ClinicalTrials.gov ID: NCT06458712