Status:
RECRUITING
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Yale University
New York Presbyterian Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-44 years
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 menopaus...
Eligibility Criteria
Inclusion
- 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.
- The participant is female.
- The patient has a known BRCA mutation.
- Have regular menstrual (21-35 days); 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. Exceptions are made for patients who have been pregnant in the last 12 months and patients with IUDs or a LARC.
- Subject Inclusion:
- For affected BRCA1 and BRCA2 mutation carriers, affected women with non-BRCA mutations, and BC patients with no mutations (control)
- 1 . Premenopausal women age 21-45 with stage 0-3 breast cancer. 2. No prior ovarian surgery or ovarian disease. 3. No prior chemotherapy. 4. Regular menstrual periods (21-35 days), no PCOS. 5. No hormonal contraception within the prior 4 weeks. 6. 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.
- 7\. Receiving an anthracycline (typically doxorubicin/Adriamycin) and Cy (AC)-based chemotherapy protocol.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
609 Patients enrolled
Trial Details
Trial ID
NCT00823654
Start Date
January 1 2009
End Date
January 1 2027
Last Update
October 14 2025
Active Locations (8)
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1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725