Clinical Trials for Breast Cancer

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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 Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating 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.

TrialFetch AI summary: Adults with metastatic or locally recurrent unresectable triple-negative breast cancer (measurable disease; ECOG 0–2) receive low-dose oral cyclophosphamide plus axatilimab (CSF-1R–blocking antibody to modulate tumor-associated macrophages/myeloid suppression) combined with fixed standard-dose retifanlimab (PD-1 inhibitor). This single-arm dose-finding study focuses on safety/tolerability and identifying recommended doses for the cyclophosphamide/axatilimab additions.

ClinicalTrials.gov ID: NCT06959537

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability

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 metastatic/recurrent or locally advanced measurable solid tumors (ECOG 0–1) whose CLIA tumor testing shows POLE/POLD1 mutations or BRCA1/2 mutations (with breast/ovarian cancers capped at 10 total in the BRCA cohort) and no prior PD-1/PD-L1/PD-L2 therapy. Patients receive single-agent pembrolizumab IV every 3 weeks, a PD-1–blocking monoclonal antibody that restores antitumor T-cell activity.

ClinicalTrials.gov ID: NCT03428802

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients With Metastatic Breast Cancer With Liver Dominant 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.

TrialFetch AI summary: Adults with HER2-negative metastatic breast cancer (including triple-negative) and liver-dominant measurable metastases (≤50% liver involvement, limited extrahepatic disease; ECOG 0–1) who have progressed on endocrine therapy + CDK4/6 if HR+ and generally after/unsuitable for a topo-1 payload ADC are randomized to liver-directed induction with melphalan via hepatic arterial infusion using the Melphalan/HDS extracorporeal filtration system (DNA-alkylating/crosslinking agent; aims to boost intrahepatic exposure while limiting systemic toxicity) for up to 2 cycles followed by single-agent chemotherapy (eribulin, vinorelbine, or capecitabine) vs the same physician’s-choice single-agent chemotherapy alone. Primary outcome is hepatic progression-free survival.

ClinicalTrials.gov ID: NCT06875128

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or 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: The trial evaluates the investigational antibody-drug conjugate XB010, which targets the 5T4 antigen to inhibit tumor growth, in adults with locally advanced or metastatic solid tumors who lack alternative treatment options; it assesses XB010 as both a monotherapy and in combination with pembrolizumab across various tumor types including non-small cell lung cancer, hormone-receptor-positive and triple-negative breast cancer, head and neck, and esophageal squamous cell cancers.

ClinicalTrials.gov ID: NCT06545331