Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer BRCA Mutations

Memorial Sloan Kettering Cancer Center8 sites in 1 country609 target enrollmentJanuary 1, 2009

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 609
Locations: 8
Primary Endpoint: characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. The hormones that researchers will check are anti-Mullerian hormone (AMH), estradiol and follicle stimulating hormone (FSH). The researchers will do this before, during, and after cancer treatment. The researchers will also ask you to fill out questionnaires about your menstrual cycle (your periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.

Registry

clinicaltrials.gov

Start Date

January 1, 2009

End Date

January 1, 2027

Last Updated

6 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For Premenopausal Women with Early Stage Breast Cancer
•Participant is between 18-44 years old.
•Participant is premenopausal.
•Participant is female.
•Participant has a known breast cancer diagnosis of AJCC Stage 0-III breast cancer, regardless of hormone-receptor status or HER2-overexpression, before the start of planned adjuvant or neoadjuvant chemotherapy and/or hormonal therapy.
•The chemotherapy regimen must be either CMF, anthracycline-containing, or taxane-containing. If hormonal therapy is planned, the regimen must be limited to tamoxifen All biologics are allowed in addition to the above therapies.
•The participant has regular menstrual cycles; note: patients can have no more than 1 irregular cycle (too early or too late) within the past year and/or at least 10 spontaneous cycles within the past year. Exceptions are made for patients who have been pregnant in the last 12 months and patients with IUDs or a LARC.
•Subject Inclusion:
•For Unaffected High Risk Premenopausal Women with BRCA mutations
•The participant is between 25 and 45 years of age.

Exclusion Criteria

•For Cohort of Premenopausal Women with Early Stage Breast Cancer
•Prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.
•Ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region.
•Plans for risk-reducing bilateral oophorectomy within one year of completion of chemotherapy.
•Prior known infertility; infertility is defined as one year of inability to conceive despite unprotected intercourse and/or the need to use medication (e.g clomiphene) or assisted reproductive technology (e.g. intrauterine insemination or in vitro fertilization) to attempt pregnancy.
•Family history of a first-degree relative with non-surgical menopause \< age 40
•Current pregnancy.
•Subject Exclusion Criteria:
•For Unaffected High Risk Premenopausal Women with BRCA mutation
•Participant has therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.

Outcomes

Primary Outcomes

characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)

Time Frame: 2 years

in premenopausal breast cancer patients \& to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.

Secondary Outcomes

To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer patients and BRCA mutation carriers.(2 years)
To study sexual health and function in unaffected high risk BRCA mutation carriers(2 years)
To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer patients and unaffected high risk BRCA mutation carriers.(2 years)
To describe the impact of commonly used therapies for early-stage breast cancer on self-reported monthly menstrual cycles and future pregnancy/reproductive health.(2 years)
To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women.(2 years)