RecruitingPhase 2NCT05693766

Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)


Sponsor

Sonya Reid

Enrollment

64 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether genetic tumor profiling can guide which chemotherapy is best for people with hormone receptor-positive, HER2-negative advanced breast cancer — a type of breast cancer that feeds on estrogen or progesterone signals. It focuses on diverse patient populations who have already tried hormone-blocking therapies. **You may be eligible if...** - You are 18 or older with stage IV breast cancer (or locally advanced breast cancer that can't be surgically removed) that is ER+ and/or PR+ and HER2-negative - You have previously received an aromatase inhibitor or similar hormone-blocking drug plus a CDK4/6 inhibitor - Your performance level allows you to carry out daily activities with minimal limitation - You have at least one measurable or evaluable area of cancer **You may NOT be eligible if...** - You have already received chemotherapy for metastatic disease - You have had another cancer in the last 2 years (some exceptions apply) - You are pregnant or breastfeeding - You have unresolved significant side effects from previous treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

2000 mg taken by mouth twice daily for 7 days on, 7 days off

OTHEREndocrine-therapy

Endocrine therapy administered

OTHERMammoPrint ® and BluePrint assays

Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays


Locations(3)

University of Alabama Birmingham

Birmingham, Alabama, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05693766


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