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NCT Number: NCT06806930

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

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

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Key information

Conditions

Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Breast Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

George Washington-Medical Faculty Associates

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

Location status: Recruiting

Location contact

Richard Lush, PhD

CONTACT

[email protected]

202-994-0329

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neoadjuvant endocrine therapy

Drug

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

Primary outcomes

  1. Response to neoadjuvant endocrine therapy (NET)

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

    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.

Secondary outcomes

  1. 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

    Preoperative Endocrine Prognostic Index (PEPI) score is determined from surgical pathology report. The score ranges from 0 to 12. The score is a composite of tumor size, nodal status, Ki67 level, and ER status. Higher scores indicate a worse outcome (increased risk of relapse), while a score of 0 (PEPI-0) represents a superior prognosis.

  2. 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

    Physicians will make a prediction of what the Ki67 will be in the surgical pathology specimen. It will correlate with the surgical pathology report data recorded by pathologist. Ki67 measures the proportion of actively dividing cancer cells. Higher scores indicate a worse outcome (higher cell proliferation and potentially more aggressive disease). Scores range from 0% to 100%.

Study contacts

Contact information is provided by the study sponsor or research team.

Pavani Chalasani, MD

CONTACT

[email protected]

202-741-2277

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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