Investigating the Impact of Tamoxifen Therapy on Ovarian Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01384526
First received: June 24, 2011
Last updated: March 27, 2013
Last verified: March 2013

June 24, 2011
March 27, 2013
June 2011
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01384526 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Investigating the Impact of Tamoxifen Therapy on Ovarian Aging
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

  • Breast Cancer
  • Fertility
Not Provided
  • history of hormone therapy
  • no history of hormone therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2014
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Female
  2. ≥25 years of age at the time of study enrollment
  3. Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ, or determined to be high risk for primary breast cancer
  4. If endocrine therapy was used, women must have completed at least 2 years of endocrine therapy as defined by either

    1. Tamoxifen alone
    2. Ovarian suppression plus tamoxifen or aromatase inhibitor
    3. Ovarian suppression alone
  5. 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.
  6. 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.
  7. 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
  8. For the biomarker assessments, patient must have had regular periods the last 3 months.

Exclusion Criteria

  1. Evidence for either local recurrence following use of adjuvant systemic therapy or evidence for distant recurrence of breast cancer.
  2. Prior history of ovarian surgery or manipulation
  3. Mother with premature ovarian failure as defined by onset of menopause at age <40
  4. Prior chemotherapy exposure
  5. Prior history of endometriosis, anovulation or documented infertility
  6. Pregnant at the time of study enrollment
Female
25 Years and older
No
Contact: A. Jo Chien, MD 415-885-7577 jo.chien@ucsf.edu
Contact: Mitch Rosen, MD 415-885-7870 RosenM@obgyn.ucsf.edu
United States
 
NCT01384526
025950
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: A. Jo Chien, MD University of California, San Francisco
Principal Investigator: Mitch Rosen, MD UCSF Center for Reproductive Health
University of California, San Francisco
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP