Recruiting

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

ClinicalTrials.gov IDNCT07340541

PhasePHASE2

Enrollment700

SponsorUNC Lineberger Comprehensive Cancer Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma

About this study

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.

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

Primary outcomes

Intra-Individual Progression-Free Survival (PFS) (Up to 5 years)

Eligibility information

Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgement of the investigator. * Age ≥ 18 years of age at the time of consent * ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale). * Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol Exclusion Criteria: * Inaccessible metastatic lesion to research biopsy * Subject has already initiated 2nd line therapy * Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation

Study locations

Yale Cancer Center Clinical Trials Office, New Haven, Connecticut 06519 United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland 21287 United States
Mayo Clinic, Rochester, Minnesota 55905 United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7305 United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania 19104 United States
Baylor College of Medicine, Houston, Texas 77030 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.