Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT06806930
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Oct 1, 2024
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort A: Short Duration NET
    Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
  • Active Comparator: Cohort B: Intermediate Duration NET
    Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
  • Active Comparator: Cohort C: Extended Duration NET
    Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks

Primary Outcome Measure

Response to neoadjuvant endocrine therapy (NET) [ Time Frame: From enrollment to the end of treatment at <=52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
George Washington-Medical Faculty AssociatesWashington D.C.District of Columbia20037
Richard Lush, PhD
[email protected]
202-994-0329

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George Washington-Medical Faculty Associates· Washington D.C., DC

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