Expired Study
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San Francisco, California 94115


Purpose:

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.


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 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


Study is Available At:


Original ID:

025950


NCT ID:

NCT01384526


Secondary ID:


Study Acronym:


Brief Title:

Investigating the Impact of Tamoxifen Therapy on Ovarian Aging


Official Title:

Investigating the Impact of Tamoxifen Therapy on Ovarian Aging


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

25 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

266


Enrollment Type:

Actual


Overall Contact Information

Official Name:A. Jo Chien, MD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:June 2011
Completion Date:March 2015
Completion Type:Actual
Primary Completion Date:March 2015
Primary Completion Type:Actual
Verification Date:March 2015
Last Changed Date:March 6, 2015
First Received Date:June 24, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:lifestyle factors, medical history, and demographics
Time Frame:assessed at time of reproductive history survey (30 minutes long, one-time assessment)
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:reproductive history
Time Frame:assessed at time of reproductive history survey (30 minutes long, one-time assessment)
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:biomarkers of ovarian reserve
Time Frame:assessed at time of ultrasound and blood draw (single day appointment, 1 hour)
Safety Issues:False
Description: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 f
Outcome Type:Primary Outcome
Measure:age of menopause onset
Time Frame:assessed at time of reproductive history survey (30 minutes long, one-time assessment)
Safety Issues:False
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 onse

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:history of hormone therapy
Study Arm Type:Other
Arm Name:no history of hormone therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Samples and Retentions

Sample 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.
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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