Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

NCT06806930 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Neo-PREDICT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

breast; cancer; HER2; carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at <=52 weeks

Secondary Outcomes (2)

• Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C

  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).

  From enrollment to the end of treatment at <=52 weeks

Study Arms (3)

Cohort A: Short Duration NET

ACTIVE COMPARATOR

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

Drug: Neoadjuvant endocrine therapy

Cohort B: Intermediate Duration NET

ACTIVE COMPARATOR

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

Drug: Neoadjuvant endocrine therapy

Cohort C: Extended Duration NET

ACTIVE COMPARATOR

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

Drug: Neoadjuvant endocrine therapy

Interventions

Neoadjuvant endocrine therapy DRUG

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

Cohort A: Short Duration NET

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington-Medical Faculty Associates

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

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Pavani Chalasani, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Division of Hematology Oncology

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 4, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)