The purpose of this study is to see how cancer treatment affects the ovaries, such as the impact on conceiving a child or the early onset of menopause. Comparatively, the study will also look at high-risk women with BRCA1/2 mutations (and no evidence of breast or ovarian cancer).

The study will check blood levels of hormones that the ovaries produce and will use questionnaires to gather information about participant menstrual cycles, health, and pregnancies.

This Study is Open To:

For Premenopausal Women with Breast Cancer

Premenopausal women age 18-44 with 0-III breast cancer, before the start of planned chemotherapy and/or hormonal therapy
Have regular menstrual cycles

For High-Risk Premenopausal Women with mutation

Premenopausal Women ages 25-45 with known mutation
No history of breast or ovarian cancer
Have regular menstrual cycles

This Study is NOT Open To:

Patients will be excluded if they have:

General

Prior known infertility
Family history of a with non-surgical menopause < age 40
Current pregnancy

Exclusion Criteria: For Premenopausal Women with Breast Cancer

Had prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or .
Had an ovarian resection, unilateral or oophorectomy, hysterectomy or radiation to pelvic region.
Plans for risk-reducing oophorectomy within one year of completion of chemotherapy.

Exclusion Criteria: For High-Risk Premenopausal Women with mutation

Had prior chemotherapy or for breast cancer or any other cancer
Had an ovarian resection, unilateral or oophorectomy, hysterectomy, radiation to pelvic region, or ovarian disease (e.g. polycystic ovarian syndrome).
Plans for risk-reducing oophorectomy within one year

What the Study Involves

The study will enroll two groups of participants:

Premenopausal women with breast cancer
High-risk women with mutations (and no evidence of breast or ovarian cancer)

Patients in both of the study groups will undergo blood draws, complete questionnaires, and provide monthly menstrual calendars to the study team at intervals for approximately two years.

For the high-risk women with mutations (and no evidence of breast or ovarian cancer), they have an option to participate in annual follow-up for an additional three years.

Study Contact Information:

For additional information, please contact:

Shari Goldfarb, MD at: 646-888-5080

Kimberly Van Zee, MD at: 646-888-5362

New Jersey

City: Basking Ridge RECRUITING
Facility: Memorial Sloan Kettering Basking Ridge
Contact Info:
646-888-5080

City: Middletown RECRUITING
Facility: Memorial Sloan Kettering Monmouth
Contact Info:
646-888-5080

City: Montvale RECRUITING
Facility: Memorial Sloan Kettering Bergen
Contact Info:
646-888-5080

New York

City: Commack RECRUITING
Facility: Memorial Sloan Kettering Commack
Contact Info:
646-888-5080

City: Harrison RECRUITING
Facility: Memorial Sloan Kettering Westchester
Contact Info:
646-888-5080

City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
646-888-5080
646-888-6898
Shari Goldfarb, MD

City: Uniondale RECRUITING
Facility: Memorial Sloan Kettering Nassau
Contact Info:
646-888-5080

Prevention

Study for premenopausal women with early-stage breast cancer and high-risk women with BRCA mutations and no evidence of breast or ovarian cancer

Clinicaltrials.gov identifier:
NCT00823654

Study Contact Information:

For additional information, please contact:

Shari Goldfarb, MD at: 646-888-5080

Kimberly Van Zee, MD at: 646-888-5362

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

Prevention

Study Contact Information:

About the Study

This Study is Open To:

This Study is NOT Open To:

What the Study Involves

Study Contact Information:

Locations:

New Jersey

New York

Prevention

Study Contact Information:

Knowledge Can Save Lives