No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
700 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with specific types of metastatic breast cancer to evaluate new treatment options. Participants will provide their medical data and receive standard therapies based on their tumor characteristics.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I can provide written consent to participate.
I am willing to follow study procedures.
I have a performance status of 0-2.
You may not be able to join if
I have a metastatic lesion that cannot be reached for a biopsy.
I have already started a second-line therapy.
I have a condition that my doctor thinks makes me inappropriate for the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 tu…
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.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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 co…
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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