Clinical Trials for Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

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.

HealthScout AI summary: This trial is enrolling adults with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer who are either PD-L1 negative or PD-L1 positive but refractory to or ineligible for checkpoint inhibitor therapy, comparing the Trop-2-directed antibody-drug conjugate sacituzumab govitecan to standard chemotherapy regimens (paclitaxel, nab-paclitaxel, or gemcitabine/carboplatin).

ClinicalTrials.gov ID: NCT05382299

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

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.

HealthScout AI summary: This trial enrolls adults with newly diagnosed, untreated de novo HER2-positive metastatic breast cancer (including those with stable, treated brain metastases), testing a sequential regimen of standard HER2-targeted therapies: taxane/trastuzumab/pertuzumab, then trastuzumab deruxtecan (HER2-targeted ADC with a topoisomerase I payload), followed by T-DM1 plus tucatinib (HER2 TKI), and finally trastuzumab/pertuzumab/tucatinib, with the intent to intensify therapy upfront and then discontinue treatment.

ClinicalTrials.gov ID: NCT06439693

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.

HealthScout 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.

HealthScout 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

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

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

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors, specifically HR+/HER2- breast cancer progressed after standard therapy or CCNE1-amplified malignancies (including ovarian, endometrial, TNBC), to receive AVZO-021, an oral selective CDK2 inhibitor targeting cell cycle dysregulation, as monotherapy or in combination with standard agents. Patients must have measurable disease, ECOG 0–1, and no prior CDK2 inhibitor exposure.

ClinicalTrials.gov ID: NCT05867251

Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative 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.

HealthScout AI summary: Adults with metastatic or unresectable triple-negative breast cancer (ER/PR ≤10%, HER2−), ECOG 0–2, including those with prior PD-1/PD-L1 therapy and treated/stable brain metastases, receive paclitaxel plus pembrolizumab combined with ASTX727 (oral decitabine, a DNA methyltransferase inhibitor, and cedazuridine, a cytidine deaminase inhibitor) to evaluate safety and dosing. Up to three prior metastatic chemotherapy lines allowed; key exclusions include active autoimmune disease requiring recent immunosuppression and uncontrolled intercurrent illness.

ClinicalTrials.gov ID: NCT05673200

Pilot Study of Cemiplimab and Hepatic Radioembolization in Patients With Liver Dominant 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.

HealthScout AI summary: Adults with liver-dominant metastatic breast cancer (ECOG 0–1) previously treated with at least one line of metastatic chemotherapy and with liver tumor burden <50% receive cemiplimab (anti–PD-1 antibody) every 3 weeks combined with two sessions of hepatic Y-90 radioembolization; controlled extrahepatic disease allowed, but no cirrhosis, recent immunotherapy, or progressing/untreated extrahepatic disease. The study assesses intratumoral immune activation and safety, with biopsies around TARE sessions and response of treated hepatic lesions.

ClinicalTrials.gov ID: NCT06860815

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ 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.

HealthScout AI summary: The trial involves patients who are postmenopausal women with relapsed locally advanced or metastatic AR+/HER2-/ER+ breast cancer, focusing on the safety and efficacy of EP0062 (vosilasarm), a selective androgen receptor modulator. Participants must have previously treated, inactive cancer and meet specific cardiac and medication criteria.

ClinicalTrials.gov ID: NCT05573126

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in 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.

HealthScout AI summary: The trial investigates the safety and efficacy of BMS-986449, an orally administered investigational drug, both as a monotherapy and in combination with the anti-PD-1 antibody nivolumab, in patients with advanced, unresectable, or metastatic solid tumors, with specific cohorts for non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

ClinicalTrials.gov ID: NCT05888831

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

HealthScout AI summary: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381