A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

Inclusion Criteria

• •Subjects must be women with a histologically confirmed invasive adenocarcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease.
• •Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients may receive concurrent trastuzumab as indicated. If a patient has not yet undergone final surgical resection, it must be highly likely (but is not required to be definite) that the patient will be treated with adjuvant chemotherapy.
• •Patients must have:
• •* Reached their 25th birthday and not yet reached their 51st birthday at the time of study enrollment, AND
• •* Had menses within 3 months prior to starting chemotherapy
• •Patients must not have received prior cytotoxic chemotherapy for any oncologic, rheumatologic, or dermatologic condition.
• •Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must not have had prior hysterectomy
• •ECOG performance status 0 - 2
• •Pregnant or nursing women may not participate. Women of reproductive potential must agree to use an effective non-hormonal contraceptive method, such as condoms, tubal ligation, non-hormonal intrauterine device, partner sterilization, and abstinence during chemotherapy.
• •All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.