Investigating the Impact of Tamoxifen Therapy on Ovarian Aging

NCT01384526 | Completed DMC

• 1 other identifier: 025950
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Fertility

Keywords

hormone therapy; ovarian aging; ovarian reserve; fertility; breast cancer

Outcome Measures

Primary Outcomes (1)

• age of menopause onset

  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.

  assessed at time of reproductive history survey (30 minutes long, one-time assessment)

Secondary Outcomes (3)

• biomarkers of ovarian reserve

  assessed at time of ultrasound and blood draw (single day appointment, 1 hour)

• reproductive history

  assessed at time of reproductive history survey (30 minutes long, one-time assessment)

• lifestyle factors, medical history, and demographics

  assessed at time of reproductive history survey (30 minutes long, one-time assessment)

Study Arms (2)

history of hormone therapy

no history of hormone therapy

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The UCSF Cancer Registry will be screened for female patients who were treated at the UCSF Breast Care Center between 1985 and 2010 and who meet the eligibility criteria listed below.

You may qualify if:

• Female
• ≥25 years of age at the time of study enrollment
• Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ, or determined to be high risk for primary breast cancer
• If endocrine therapy was used, women must have completed at least 2 years of endocrine therapy as defined by either
• Tamoxifen alone
• Ovarian suppression plus tamoxifen or aromatase inhibitor
• Ovarian suppression alone
• Women must have been premenopausal at the time of endocrine therapy initiation. Premenopausal is defined as having had a menstrual cycle within 12 months before starting treatment.
• For the biomarker assessments, patients must be off all endocrine therapy (tamoxifen, ovarian suppression with goserelin or leuprolide, or aromatase inhibitor) for at least 6 months prior to study enrollment.
• For the biomarker assessments, patient must be off hormone contraceptives, fertility treatments, or other hormone therapies for at least 3 months prior to study enrollment
• For the biomarker assessments, patient must have had regular periods the last 3 months.

You may not qualify if:

• Evidence for either local recurrence following use of adjuvant systemic therapy or evidence for distant recurrence of breast cancer.
• Prior history of ovarian surgery or manipulation
• Mother with premature ovarian failure as defined by onset of menopause at age \<40
• Prior chemotherapy exposure
• Prior history of endometriosis, anovulation or documented infertility
• Pregnant at the time of study enrollment

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• A. Jo Chien, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Mitch Rosen, MD

  UCSF Center for Reproductive Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 29, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

US (1)