Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (POWER PIINC)
|ClinicalTrials.gov Identifier: NCT01614210|
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : December 13, 2017
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer||Drug: Tamoxifen Procedure: Breast cancer surgery||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
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
- Change in Ki67 Expression in Tumors [ Time Frame: 7 days ]Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.
- Evaluate Symptom Patterns [ Time Frame: 18 months ]Evaluate symptom patterns from baseline through 18 months of follow-up (presence, severity, and bother)
- Adherence [ Time Frame: 18 months ]Evaluate 18-month endocrine therapy adherence
- Correlation Between Changes in Ki67 and Symptoms [ Time Frame: 7 days ]Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in KI67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient.
- Change in FACT-ES Symptom Scores [ Time Frame: 7 days ]Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614210
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Leigh Neumayer, MD||Huntsman Cancer Institute|