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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States,

Middletown

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Commack, Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester, Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

New York

New York Presbyterian Hospital-Weill Medical College of Cornell University, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau, Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Premenopausal female patients age 18-44 with breast cancer as defined as:
  • * Have regular menstrual cycles; patients can have no more than 1 irregular cycle (too early or too late) within the past year or were pregnant in the past 12 months, and/or at least 10 spontaneous cycles within the past year.
  • * Premenopausal Women ages 25-45 with known BRCA mutations
  • * Have regular menstrual (21-35 days); 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.
  • * No history of breast or ovary cancer.
  • * Premenopausal women age 21-45 with stage 0-3 breast cancer
  • * No prior ovarian surgery or ovarian disease
  • * No prior chemotherapy
  • * Regular menstrual periods (21-35 days), no PCOS
  • * No hormonal contraception within the prior 4 weeks
  • * Mutation testing decision based on NCCN Guidelines V1.2021: according to these Guidelines, both centers test all pre-menopausal women with breast cancer for BRCA and non-BRCA mutations which are the subject of this proposal
  • * Receiving an anthracycline (typically doxo/Adriamycin) and Cy (AC)-based chemotherapy protocol
  • * 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.

Ages Eligible for Study

18 Years to 44 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Shari Goldfarb, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-01