Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial
National Cancer Institute (NCI)
Summary
This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.
Description
PRIMARY OBJECTIVE: I. To evaluate whether the overall proportion of premenopausal tamoxifen responders (defined by absolute dense area reduction on mammogram of \> 10%) can be increased through a strategy of within-individual dose escalation among non-responders from 5 mg per day to 10 mg per day. SECONDARY OBJECTIVES: I. To assess the association of plasma levels of major tamoxifen metabolites with tamoxifen dose and breast density changes from baseline. II. To evaluate longitudinal change from baseline in serum biomarkers of tamoxifen response at each dose level: sex hormone binding glob…
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Premenopausal women at the time of enrollment defined by any of the following: * Age under 50 years and regular menstruation (most recent period within the past 3 months) * Age under 50 years and continuous hormonal contraception use and at least one intact ovary * Women who are not postmenopausal based on serum hormone levels. Women with estradiol =\< 30 pg/mL, follicle-stimulating hormone (FSH) \>= 30 IU/mL are eligible * Women with any of the following: * A history of unilateral estrogen receptor (ER) positive ductal carcinoma in situ (DCIS) with local thera…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureMammography
Undergo mammography
- OtherQuestionnaire Administration
Ancillary studies
- DrugTamoxifen
Given PO
Locations (11)
- University of Arizona Cancer Center - Prevention Research ClinicTucson, Arizona
- Northwestern UniversityChicago, Illinois
- University of Illinois College of Medicine - ChicagoChicago, Illinois
- University of Kansas Cancer CenterKansas City, Kansas
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts