Actively Recruiting

Age: 18Years - 44Years
FEMALE
Healthy Volunteers
NCT00823654

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-10-14

609

Participants Needed

8

Research Sites

939 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Y

Yale University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 44Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 to 44 years for breast cancer group, or 25 to 45 years for high-risk BRCA mutation group
  • Premenopausal status
  • Known diagnosis of early-stage breast cancer (AJCC Stage 0-III) before starting chemotherapy or hormonal therapy for breast cancer group
  • Known BRCA mutation for high-risk group
  • Chemotherapy regimen limited to CMF, anthracycline-containing, or taxane-containing for breast cancer patients
  • Hormonal therapy limited to tamoxifen if planned
  • Regular menstrual cycles with no more than one irregular cycle in the past year, or at least 10 spontaneous cycles within the past year
  • Exceptions for patients pregnant in the last 12 months or with IUDs or long-acting reversible contraception
  • No prior ovarian surgery or ovarian disease
  • No prior chemotherapy
  • No hormonal contraception within the prior 4 weeks
  • Mutation testing performed according to NCCN Guidelines
Not Eligible

You will not qualify if you...

  • Prior therapy for breast cancer or any other cancer, including chemotherapy, hormonal therapy, or immunotherapy
  • Ovarian surgery such as unilateral or bilateral oophorectomy, hysterectomy, or radiation to the pelvic region
  • Plans for risk-reducing bilateral oophorectomy within one year after chemotherapy
  • Known infertility defined as one year of inability to conceive despite unprotected intercourse or need for fertility treatments
  • Family history of a first-degree relative with non-surgical menopause before age 40
  • Current pregnancy
  • Subjects without mutation testing or positive for more than one family of ATM-Pathway gene mutations
  • Women older than 42 years
  • Chemotherapy protocols other than AC-based or CMF
  • Current smokers (smoked 100 cigarettes lifetime and currently smoking)
  • Body mass index (BMI) less than 18.5 or greater than 40

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Actively Recruiting

2

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, United States, 10065

Active, Not Recruiting

8

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

S

Shari Goldfarb, MD

CONTACT

M

Minna Lee, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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