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Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

NCT07340541 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-05-20

No results posted yet for this study

Summary

This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

Conditions

Interventions

DRUG

SERD* + abemaciclib

Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.

DRUG

SERD* + everolimus

Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.

DRUG

SERD* + everolimus or capecitabine

Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.

DRUG

SOC

standard-of-care (SOC) chemotherapy in breast cancer

DRUG

Antiandrogen

Antiandrogen therapy

Sponsors & Collaborators

  • Advanced Research Projects Agency for Health (ARPA-H)

    collaborator UNKNOWN

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Lisa A Carey, MD · UNC Lineberger Comprehensive Cancer Center

  • Eric Winer, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2031-06-02
Completion
2031-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340541 on ClinicalTrials.gov