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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, United States
RECRUITINGResponse 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.
Time frame: From enrollment to the end of treatment at <=52 weeks
Physicians will predict PEPI score after NET for subjects enrolled in cohort B or C
* PEPI score is determined from surgical pathology report * Physicians can predict the PEPI score and drop in Ki-67 based on tumor size, biology, and patient preference for duration pre-NET. See chart: Surgical factors PEPI Score Tumor size T1/T2 1 T3/T3 3 Node Size Negative 0 Positive 3 Ki67 Level 0-2.7% 0 \>2.7-7.3% 1 \>7.3-19.7% 1 \>19.7-53.1% 2 \>53.1% 3 ER Status Negative 3 • The physicians will be asked to predict whether the PEPI score post-surgery will be 0 (low risk of recurrence), 1 - 3 (intermediate risk of recurrence), \> 4 (high risk of recurrence). The chart above is used clarify how physicians will at the subject's PEPI score.
Time frame: From enrollment to the end of treatment at <=52 weeks
Physicians will predict Ki67 after NET
* Ki67 is assessed by pathologist in the tumor specimen obtained from surgical resection * Physicians will be asked to predict whether Ki-67 post-surgery will fall below 15% (high proliferation fraction). (see chart above for breakdown of surgical factors and PEPI score). * Concordance between the physician prediction and post-surgery PEPI values will be assessed using the kappa statistic. Concordance will be assessed using the kappa statistic. Thirty women per cohort will allow estimation of the percent with response to NET with standard error \< 0.10.
Time frame: From enrollment to the end of treatment at <=52 weeks
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