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Clinical trialNCT07340541RecruitingPhase 2Interventional

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

SponsorUNC Lineberger Comprehensive Cancer CenterEnrollment700Breast CancerEstrogen-receptor-positive Breast CancerHormone Receptor Negative Breast CarcinomaMetastatic Breast CancerTriple Negative Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Yale Cancer Center Clinical Trials Office

    New Haven, Connecticut, United States

    Eric Winer, MD →
    Recruiting
  • Johns Hopkins University/sidney Kimmel Cancer Center

    Baltimore, Maryland, United States

    Cesar Santa-Maria, MD
    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, United States

    Karthik Giridhar, MD
    Not, yet, recruiting
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States

    Lisa A Carey, MD →
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Antiandrogen →SERD* + abemaciclib →SERD* + everolimus →SERD* + everolimus or capecitabine →2,2-Dimethyl-4-(chloromethyl)-1,3-dioxa-2-silacyclopentane →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Feb 2026
Primary completion
2 Jun 2031
Completion
2 Jun 2031
Last update posted
31 Jul 2026
Registered enrollment
700
Registry id
NCT07340541
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.