RecruitingInterventionalPhase 2

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

NCT ID: NCT06806930Sponsor: George Washington UniversityLast updated: 2026-03-03

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

Arms & interventions

DrugNeoadjuvant endocrine therapy
Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
DrugNeoadjuvant endocrine therapy
Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
DrugNeoadjuvant endocrine therapy
Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks

Outcome measures

Primary

Response to neoadjuvant endocrine therapy (NET)
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins \>1mm; Failure is defined as margins ≤1mm.
Time frame: From enrollment to the end of treatment at <=52 weeks

Secondary

Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C
Time frame: From enrollment to the end of treatment at <=52 weeks
Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).
Time frame: From enrollment to the end of treatment at <=52 weeks

Eligibility criteria

Sex: AllAge: 21 Years and olderHealthy volunteers: No

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 locations (1)

George Washington-Medical Faculty Associates

Washington D.C., District of Columbia, 20037

Recruiting

Richard Lush, PhD · Contact

202-994-0329 rmlush3@gwu.edu