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

Description

The purpose of this study is to see how the cancer treatment affects the ovaries. Cancer treatment can make it hard for a person to conceive a child in the future. It may also bring on early menopause. We will check blood levels of hormones that the ovaries produce. We will do this before, during, and after the cancer treatment. We will also ask the patient to fill out questionnaires about their menstrual cycle (periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.

Study Start Date

January 2009

Estimated Completion Date

January 2017

Interventions

  • Other: Blood draw and questionaires
  • Other: Blood draw and questionnaires

Specialties

  • Obstetrics & Gynecology: Breast,Menopausal Medicine
  • Family Medicine: Women`s Health
  • Oncology: Breast
  • Physician Assistant: Obstetrics/Gynecology,Women`s Health

MeSH Terms

  • Breast Neoplasms

Study ID

Memorial Sloan-Kettering Cancer Center -- 08-156

Status

Unknown

Trial ID

NCT00823654

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

320

Sponsor

Memorial Sloan-Kettering Cancer Center

Inclusion Criteria

  • Premenopausal female patients age 18-44 with breast cancer as defined as: a. 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. If chemotherapy is planned, the regimen must be either CMF, anthracycline containing, or taxane containing. If hormonal therapy is planned, the regimen must be limited to tamoxifen. All biologics (e.g. bevacizumab, trastuzumab, lapatinib, etc.) are allowed in addition to the above therapies.
  • ECOG performance status 0-1
  • Have regular menstrual cycles
  • 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.

Exclusion Criteria

  • 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.

Gender

Female

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Cancer Center Suffolk - Commack, New York 26.2 miles Maura Dickler MD 646-888-4560 None
Memorial Sloan Kettering Cancer Center Suffolk - Commack, New York 26.2 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles None None None
New York Presbyterian HospitalWeill Medical College of Cornell University - New York, New York 50.7 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Maura Dickler MD 646-888-4560 None
New York Presbyterian HospitalWeill Medical College of Cornell University - New York, New York 50.7 miles Tessa Cigler MD None None

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