Recruiting
Phase 2

Neo-PREDICT

Sponsor:

George Washington University

Code:

NCT06806930

Conditions

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage III

Carcinoma, Breast

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Neoadjuvant endocrine therapy

Neoadjuvant endocrine therapy

Neoadjuvant endocrine therapy

Study Details

Brief 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

Conditions

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage III

Carcinoma, Breast

Study ID

NCT06806930

Start date

Oct 1, 2024

Status verified date

Feb, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cohort A: Short Duration NET

Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks)

active comparator: Cohort B: Intermediate Duration NET

Patients in this cohort can be treated with NET > 8weeks but <=24 weeks

active comparator: Cohort C: Extended Duration NET

Patients in this cohort can be treated with NET >24 weeks but <= 52 weeks

Interventions

Neoadjuvant endocrine therapy

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

Neoadjuvant endocrine therapy

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

Neoadjuvant endocrine therapy

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

Primary outcome measure

  • Response to neoadjuvant endocrine therapy (NET) [ Time Frame: From enrollment to the end of treatment at <=52 weeks ]

Central Contacts and Locations

Central contacts

Pavani Chalasani, MD

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

Locations

George Washington-Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Richard Lush, PhD

202-994-0329rmlush3@gwu.edu

More Information

Sponsor

George Washington University

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • breast
  • cancer
  • HER2
  • carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-03-03.