Actively Recruiting
Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
Led by George Washington University · Updated on 2026-03-03
90
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the investigational nature of the study and all relevant details
- Able to provide written informed consent
- Confirmed diagnosis of invasive breast carcinoma by biopsy
- Clinical stage 1 to 3 breast cancer
- Candidate for surgical removal of tumor
- Estrogen receptor positive with >10% stained cells on recent biopsy
- HER2 negative or HER2 low breast cancer, not eligible for HER2-targeted therapy
- Able to take oral medications
- Willing and able to follow scheduled visits, treatment, and research follow-up
- Age 21 years or older
You will not qualify if you...
- Unable to comply with taking neoadjuvant endocrine therapy (NET)
- Unable to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
P
Pavani Chalasani, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here