Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausa
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 chec
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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/o |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Locations | Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States (+2 more sites) |
| Start date | 2009-01 |
| NCT ID | NCT00823654 |
| Official listing | https://clinicaltrials.gov/study/NCT00823654 |