RecruitingPhase 2NCT06806930

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)


Sponsor

George Washington University

Enrollment

90 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are: 1. How breast cancer responds to endocrine therapy given prior to surgery? 2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will: * receive endocrine therapy as part of regular care for breast cancer * consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor * participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether certain biological and clinical factors can predict how well breast cancer patients respond to hormone-blocking therapy (endocrine therapy) given before surgery — a treatment called neoadjuvant endocrine therapy — in people with hormone receptor-positive, HER2-negative breast cancer. **You may be eligible if...** - You are 21 or older - You have confirmed invasive breast cancer (Stage 1 to 3) that is hormone receptor-positive (estrogen receptor positive in more than 10% of cells) and HER2-negative or HER2-low - You are a candidate for surgery - You are able to take oral medication **You may NOT be eligible if...** - You are unable to take the hormone-blocking treatment orally - You are unable to comply with study procedures and follow-up visits 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

DRUGNeoadjuvant endocrine therapy

Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)

DRUGNeoadjuvant endocrine therapy

Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks

DRUGNeoadjuvant endocrine therapy

Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks


Locations(1)

George Washington-Medical Faculty Associates

Washington D.C., District of Columbia, United States

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NCT06806930


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