Clinical Trials for Breast Cancer

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

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

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 previously treated metastatic triple-negative breast cancer (ER/PR ≤10%, HER2–; ECOG 0–1/2) receive sacituzumab govitecan (TROP2-directed SN-38 ADC) plus naxitamab, a humanized anti-GD2 monoclonal antibody, to assess safety and antitumor activity. Excludes prior anti-GD2 or metastatic-setting TROP2 ADC use and active CNS metastases.

ClinicalTrials.gov ID: NCT07011654

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

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 advanced/metastatic solid tumors refractory to standard therapy (mCRPC, metastatic breast cancer subtypes including TNBC, HR+/HER2− or HER2-low, HR−/HER2+, NSCLC, CRC, PDAC) receive MBRC-201, an investigational antibody‑drug conjugate targeting a tumor-associated antigen and delivering a likely topoisomerase I inhibitor payload. Requires ECOG 0–2 and measurable disease in expansion/Phase 2; excludes active CNS disease and prior camptothecin‑payload ADCs in later phases.

ClinicalTrials.gov ID: NCT07145255

Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive 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: PD-L1–positive metastatic triple-negative breast cancer after one prior line including pembrolizumab (ECOG 0–1; stable brain mets allowed) randomized to sacituzumab govitecan (Trop-2–directed SN-38 ADC) plus nivolumab (PD-1 inhibitor) with or without relatlimab (LAG-3 inhibitor). Compares whether adding LAG-3 blockade to PD-1 with SG improves activity in checkpoint-exposed mTNBC.

ClinicalTrials.gov ID: NCT06963905

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

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

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: This trial involves patients with advanced or metastatic solid tumors expressing Nectin-4, including urothelial carcinoma, triple-negative breast cancer, non-small cell lung cancer, and ovarian cancer, who have exhausted standard therapy options. It evaluates LY4052031, an antibody-drug conjugate that targets Nectin-4 to deliver a topoisomerase I inhibitor, aiming to assess its safety, tolerability, and efficacy in these patients.

ClinicalTrials.gov ID: NCT06465069

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal 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.

HealthScout AI summary: This trial involves patients with locally advanced or metastatic pancreatic, lung, breast, and colorectal cancers who have progressed after standard treatments and exhibit tumor uptake of [68Ga]Ga-NNS309. It evaluates the safety and preliminary activity of the investigational radioligand [177Lu]Lu-NNS309, which targets specific tumor markers, though its exact mechanism of action is undisclosed.

ClinicalTrials.gov ID: NCT06562192