Clinical Trial

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Recruiting Phase 2
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-29; most recent amendment 2026-02-27.
Trial Details
NCT Number NCT06806930
Lead Sponsor George Washington University
Conditions Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Carcinoma, Breast
Enrollment 90 participants
Start Date 2024-10-01
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-03