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Predicting Response to Hormone Therapy for Early Breast Cancer

This study, called Neo-PREDICT, is looking at how different lengths of hormone-blocking therapy (neoadjuvant endocrine therapy) given before surgery affect breast cancer. Participants with early-stage breast cancer (Stage I, II, or III) will receive this therapy for a short (up to 8 weeks), intermediate (8 to 24 weeks), or extended (24 to 52 weeks) duration. The main goal is to understand how breast cancer responds to this treatment and to predict a score that helps understand the tumor's response. The study aims to enroll 90 participants and is currently unclear regarding its recruitment status.

Study design
This interventional study plans to enroll 90 participants with breast cancer across three groups, each receiving neoadjuvant endocrine therapy for a different length of time.
What's involved
Participants will receive neoadjuvant endocrine therapy for up to 52 weeks, with their response to treatment being measured during this time.
Compensation
Not stated in the trial record.
Follow-up
Response to treatment will be measured from enrollment until the end of treatment, up to 52 weeks.

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NCT06806930

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Recruiting
PHASE2Ages 21+InterventionalTreatment
George Washington University
~90 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Neoadjuvant endocrine therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response to neoadjuvant endocrine therapy (NET)
Measured over From enrollment to the end of treatment at <=52 weeks

Conditions

Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Carcinoma, Breast

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Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

Pavani Chalasani, MD
[email protected]
202-741-2277
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Eligibility criteria

Inclusion

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

Inability to comply taking NET
Inability to comply to study procedures

What this trial measures

  • Response to neoadjuvant endocrine therapy (NET)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.