Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorGeorge Washington University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to comply taking NET
Inability to comply to study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Neoadjuvant endocrine therapy
DrugCohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
Neoadjuvant endocrine therapy
DrugCohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
Neoadjuvant endocrine therapy
DrugCohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Cohort A: Short Duration NETActive comparator 1 intervention
Group B: Cohort B: Intermediate Duration NETActive comparator 1 intervention
Group C: Cohort C: Extended Duration NETActive comparator 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at <=52 weeksSecondary outcomes
1
Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C
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.
Time frame
From enrollment to the end of treatment at <=52 weeks2
Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).
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%.
Time frame
From enrollment to the end of treatment at <=52 weeksSponsors and contacts
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Source ClinicalTrials.gov