Breast Cancer
Conditions
Keywords
Breast, Questionaires, Blood draw, BRCA1, BRCA2, 08-156
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 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.
Interventions
Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive health questionnaire (Appendix A)/menstrual calendar (Appendix C) / sexual health questionnaires (Appendices E, F, G) ↓ Start planned therapy (or observation) ↓ Evaluation at completion of chemotherapy Blood draw and collection of monthly menstrual calendars ↓ One year post chemo Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) ↓ Annual follow-up x 3 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) )/ sexual health questionnaires (Appendices E, F, G)
Sponsors
Yale University
New York Presbyterian Hospital
Weill Medical College of Cornell University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
For Premenopausal Women with Early Stage Breast Cancer 1. Participant is between 18-44 years old. 2. Participant is premenopausal. 3. Participant is female. 4. 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. 5. 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. 6. 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 1. The participant is between 25 and 45 years of age. 2. The participant is female. 3. The patient has a known BRCA mutation. 4. 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 criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned) | 2 years | in premenopausal breast cancer patients & to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers. |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer patients and BRCA mutation carriers. | 2 years |
| To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer patients and unaffected high risk BRCA mutation carriers. | 2 years |
| To describe the impact of commonly used therapies for early-stage breast cancer on self-reported monthly menstrual cycles and future pregnancy/reproductive health. | 2 years |
| To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women. | 2 years |
| To study sexual health and function in unaffected high risk BRCA mutation carriers | 2 years |
Countries
United States
Contacts
Primary ContactShari Goldfarb, MD
Backup ContactMinna Lee, MD
Outcome results
None listed