Investigating the Impact of Tamoxifen Therapy on Ovarian Aging
Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Understanding the effects of hormone therapy on ovarian aging will help breast cancer patients of reproductive age make more informed and empowered decisions regarding their treatment. The purpose of this study is to explore the relationship between tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on age and menopausal status. Women who read about the study from clinicaltrials.gov and contact the study coordinator will also be considered for enrollment. The age of menopause onset will be assessed through surveys and will be compared to the accepted national average age of natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging (OVA) study.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Investigating the Impact of Tamoxifen Therapy on Ovarian Aging|
- age of menopause onset [ Time Frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment) ] [ Designated as safety issue: No ]The primary aim of this study is to determine the mean age of menopause onset in a cohort of women who have completed a course of tamoxifen therapy and to compare this age with the accepted national average age of natural menopause. Age of menopause onset which is defined as the year of the last menstrual period minus patient's birth year.
- biomarkers of ovarian reserve [ Time Frame: assessed at time of ultrasound and blood draw (single day appointment, 1 hour) ] [ Designated as safety issue: No ]A secondary aim is to compare biomarkers of ovarian reserve in premenopausal women between ages 25-45 who have been previously treated with tamoxifen with those of age- and ethnicity-matched healthy controls. The primary biomarker of interest is antral follicle count (AFC). Other biomarkers that will be measured include anti-Mullerian hormone (AMH), inhibin B, FSH, and estradiol levels.
- reproductive history [ Time Frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment) ] [ Designated as safety issue: No ]A secondary aim is to characterize the reproductive histories of women who have completed a course of endocrine therapy for the prevention or treatment of breast cancer.
- lifestyle factors, medical history, and demographics [ Time Frame: assessed at time of reproductive history survey (30 minutes long, one-time assessment) ] [ Designated as safety issue: No ]A secondary aim is to correlate biomarkers of ovarian age and age of menopause onset with lifestyle factors, medical history, and demographics in pre- and postmenopausal women previously treated with endocrine therapy, accounting for age and ethnicity.
Biospecimen Retention: Samples With DNA
Serum AMH, FSH, estradiol, and Inhibin B will be measured. Blood will be collected and processed by the UCSF Center for Reproductive Health. Serum samples will be stored at -80oC in a designated freezer with an alarm system. Biomarker assessments will be performed by Quest Laboratories under standard quality control.
|Study Start Date:||June 2011|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
|history of hormone therapy|
|no history of hormone therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384526
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||A. Jo Chien, MD||University of California, San Francisco|
|Principal Investigator:||Mitch Rosen, MD||UCSF Center for Reproductive Health|