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Investigating the Impact of Tamoxifen Therapy on Ovarian Aging

25 Years
Open (Enrolling)
Breast Cancer, Fertility

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Trial Information

Investigating the Impact of Tamoxifen Therapy on Ovarian Aging

Inclusion Criteria

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

8. For the biomarker assessments, patient must have had regular periods the last 3

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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

age of menopause onset

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

A. Jo Chien, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Fertility
  • hormone therapy
  • ovarian aging
  • ovarian reserve
  • fertility
  • breast cancer
  • Breast Neoplasms



UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115