Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (POWER PIINC)
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.
Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer
Procedure: Breast cancer surgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance|
- Reduction in Ki67 expression in tumors [ Time Frame: 36 months ] [ Designated as safety issue: No ]Demonstrate a significant reduction in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.
- Evaluate symptom patterns [ Time Frame: 36 months ] [ Designated as safety issue: No ]Evaluate symptom patterns from baseline through 18 months of follow-up (presence, severity, and bother)
- Adherence [ Time Frame: 36 months ] [ Designated as safety issue: No ]Evaluate 18-month endocrine therapy adherence
- Correlation between changes in Ki67 and symptoms [ Time Frame: 36 months ] [ Designated as safety issue: No ]Evaluate correlation between changes in Ki67 expression and symptom scores
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: All patients
All patients enrolled in the study.
All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.Procedure: Breast cancer surgery
Breast cancer surgery
Patients who are eligible (newly diagnosed hormone positive clinical stage 1 or 2 breast cancer) will be approached about the study. If they sign informed consent a prescription for 21 doses of Tamoxifen will be provided. The patient's surgery will be scheduled at a time convenient for the patient and the surgeon. Once the surgery has been scheduled, a medication calendar will be completed that allows the patient to take tamoxifen for 7 days preoperatively with the 7th dose of tamoxifen to coincide with the day before surgery. The patient will continue to take tamoxifen for 2 weeks (14 days) after surgery. Patients will then proceed along normal treatment guidelines. For those needing chemotherapy or radiation therapy, we recommend the long term endocrine therapy start at the conclusion of chemo and/or radiation treatments. For those not going on to any additional therapy, the prescription for endocrine therapy will be written at the initial post-operative visit.
Unstained slides from the formalin-fixed, paraffin-embedded tissue blocks from the patient's breast tissue from which the original diagnosis of breast cancer was made by H&E will be stained for Ki67. After endocrine therapy and subsequent resection, carcinoma will be confirmed by the participating pathologist on H&E, and Ki67 will be performed on unstained slides from a representative tissue block containing invasive carcinoma. The pathologist will circle a designated area of tumor on the H&E slide and both the H&E and immunostained (Ki67) slides will be scanned in a digital imaging device (Aperio XT Scanscope), which quantitatively analyzes the tumor designated by the pathologist with image analysis algorithms. The algorithm accurately detects regions of interest and distinguishes cells and sub-cellular objects within these target regions. It determines morphology and expression profiles per individual cell or cell compartment. For Ki67 analysis, a nuclear Immunohistochemistry (IHC) algorithm will be used.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614210
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Leigh Neumayer, MD||Huntsman Cancer Institute|