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Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

NCT06806930•George Washington University

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
•Be capable of signing and providing written consent in accordance with institutional and federal guidelines
•Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
•Clinical stage 1 to 3 breast cancer
•Candidate for surgical resection
•Estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
•HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
•Ability to take oral medication
•Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
•Age ≥ 21 years

Exclusion Criteria

•Inability to comply taking NET
•Inability to comply to study procedures

Locations (1)

George Washington-Medical Faculty Associates

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

Key Dates

Start Date

October 1, 2024

Primary Completion Date

October 1, 2028

Completion Date

October 1, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Breast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIICarcinoma, Breast

Interventions

Neoadjuvant endocrine therapy

DRUG

Neoadjuvant endocrine therapy

DRUG

Neoadjuvant endocrine therapy

DRUG

Contacts

Pavani Chalasani, MD

CONTACT

202-741-2277 pchalasani@mfa.gwu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Inclusion Criteria

Exclusion Criteria

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer

Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer