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RECRUITING
NCT06806930
PHASE2

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Sponsor: George Washington University

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-10-01

Completion Date

2028-10

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant endocrine therapy

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

DRUG

Neoadjuvant endocrine therapy

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

DRUG

Neoadjuvant 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