Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Last updated: January 29, 2025
Sponsor: George Washington University
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Neoadjuvant endocrine therapy

Clinical Study ID

NCT06806930
Neo-PREDICT
  • Ages > 21
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Be capable of understanding the investigational nature of the study and allpertinent aspects of the study

  • Be capable of signing and providing written consent in accordance with institutionaland federal guidelines

  • Histologically or cytologically confirmed diagnosis of invasive carcinoma of thebreast

  • Clinical stage 1 to 3 breast cancer

  • Candidate for surgical resection

  • Estrogen receptor > 10% positive stained cells based on most recent tumor biopsy anddocumented by a local laboratory or medical record.

  • HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy anddocumented by a local laboratory or medical record. HER2 negative tumor is definedper American Society of Clinical Oncology and the College of American Pathologistsguidelines, 2018. Patients with HER2 low tumors are eligible as long as patients arenot candidates for any HER2 directed therapy.

  • Ability to take oral medication

  • Be willing and able to comply with scheduled visits, treatment plan, and follow upwith research staff

  • Age ≥ 21 years

Exclusion

Exclusion Criteria:

  • Inability to comply taking NET

  • Inability to comply to study procedures

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Neoadjuvant endocrine therapy
Phase: 2
Study Start date:
October 03, 2024
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • George Washington-Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

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