Clinical Trials for Breast Cancer

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

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.

TrialFetch AI summary: Adults with previously treated recurrent metastatic breast cancer receive intradermal BC1 alone during dose escalation, then BC1 with cyclophosphamide, peginterferon alfa-2a, and the PD-1 inhibitor tislelizumab. BC1 is an investigational GM-CSF–secreting allogeneic breast-cancer cell therapy intended to promote tumor-antigen presentation and T-cell priming.

ClinicalTrials.gov ID: NCT06471673

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in PD-L1 Negative TNBC

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.

TrialFetch AI summary: Adults with metastatic triple-negative breast cancer progressing after 1–2 prior metastatic treatment lines receive oral ivermectin plus the anti-PD-1 antibody balstilimab or pembrolizumab. The expansion cohort requires PD-L1-negative disease; patients previously treated with a checkpoint inhibitor for metastatic disease are excluded.

ClinicalTrials.gov ID: NCT05318469

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)

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.

TrialFetch AI summary: Adults with metastatic triple-negative breast cancer, measurable brain metastases eligible for stereotactic radiosurgery, ECOG performance status 0–2, and prior taxane- and anthracycline-based chemotherapy receive radiosurgery followed by sacituzumab govitecan and zimberelimab; leptomeningeal disease is excluded. Sacituzumab govitecan is a TROP-2–directed antibody–drug conjugate that delivers SN-38, and zimberelimab is an investigational PD-1–blocking antibody.

ClinicalTrials.gov ID: NCT06238921

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants 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.

TrialFetch AI summary: Adults with recurrent advanced or metastatic breast, ovarian, castration-resistant prostate, or pancreatic cancer harboring selected deleterious HRR gene mutations receive oral EIK1004 (IMP1707) monotherapy. EIK1004 is an investigational PARP1-selective inhibitor designed to impair DNA repair and trap PARP1 on DNA while largely sparing PARP2.

ClinicalTrials.gov ID: NCT06907043

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant 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.

TrialFetch AI summary: Adults with metastatic or unresectable breast or gastrointestinal cancer that has progressed after standard therapy and expresses HER2 or EGFR receive B-Vaxx, a two-peptide HER2 vaccine emulsified in ISA 720 adjuvant. The peptides mimic HER2 sites targeted by trastuzumab and pertuzumab and are designed to induce HER2-binding antibodies.

ClinicalTrials.gov ID: NCT06414733

Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer

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.

TrialFetch AI summary: Women with previously treated HR-positive, HER2-negative advanced or metastatic breast cancer receive fulvestrant plus serabelisib, a PI3Kα inhibitor, and sapanisertib, an mTORC1/2 inhibitor, at one of two dose levels. The study evaluates safety and preliminary antitumor activity; patients previously treated with PI3K, AKT, or mTOR inhibitors are excluded.

ClinicalTrials.gov ID: NCT07558733

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other 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: Patients with advanced or metastatic urothelial carcinoma after at least one prior regimen, including those previously treated with enfortumab vedotin, or selected other solid tumors after standard options are exhausted receive intravenous LY4052031. This investigational Nectin-4–targeted antibody–drug conjugate delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06465069

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor 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 measurable, locally advanced or metastatic solid tumors and ECOG performance status 0–1 receive MDNA11 alone or with pembrolizumab. MDNA11 is a long-acting IL-2 agonist designed to favor IL-2 receptor β signaling in CD8-positive T cells and natural killer cells while limiting regulatory T-cell stimulation; pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT05086692

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally 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 inoperable locally advanced, metastatic, or recurrent solid tumors and no effective or tolerable standard options receive intravenous XB010, a 5T4-targeted antibody–drug conjugate carrying the microtubule-disrupting payload monomethyl auristatin E. Dose escalation evaluates XB010 alone or with pembrolizumab; tumor-specific expansion cohorts evaluate XB010 alone in NSCLC, breast, head and neck, esophageal, and endometrial cancers.

ClinicalTrials.gov ID: NCT06545331

A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations

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 relapsed or refractory HER2-altered advanced cancers after progression on or intolerance of their last systemic therapy receive oral IAM1363, an investigational irreversible HER2 inhibitor designed to penetrate the brain. Patients with brain metastases may enroll unless they need immediate local therapy.

ClinicalTrials.gov ID: NCT06253871