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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Short Duration NET | Active Comparator | Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks) |
|
| Cohort B: Intermediate Duration NET | Active Comparator | Patients in this cohort can be treated with NET > 8weeks but <=24 weeks |
|
| Cohort C: Extended Duration NET | Active Comparator | Patients in this cohort can be treated with NET >24 weeks but <= 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant endocrine therapy | Drug | Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at <=52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavani Chalasani, MD | Contact | 202-741-2277 | pchalasani@mfa.gwu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington-Medical Faculty Associates | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |
|
| From enrollment to the end of treatment at <=52 weeks |
| 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%. | From enrollment to the end of treatment at <=52 weeks |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |