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Biomarker-Guided breast cancer trial aims to personalize therapy

NCT ID NCT07340541

Knowledge-focused Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study is for people with metastatic breast cancer, including estrogen receptor-positive and triple-negative types. It uses biomarkers from tumors and blood to guide treatment choices, comparing how long the cancer stays controlled on the new therapy versus the previous one. The goal is to see if biomarker-driven therapy improves outcomes, with each patient acting as their own control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm estrogen-receptor negative breast cancer estrogen-receptor positive breast cancer triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Estrogen-receptor-positive breast cancer Hormone receptor negative breast carcinoma Metastatic breast cancer Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599-7305, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • University of Pennsylvania/Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Yale Cancer Center Clinical Trials Office

    RECRUITING

    New Haven, Connecticut, 06519, United States

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