Status:
COMPLETED
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
Lead Sponsor:
Lynn Henry
Conditions:
Breast Cancer
Eligibility:
FEMALE
25-50 years
Brief Summary
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual perio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00644683
Start Date
September 1 2007
End Date
September 1 2013
Last Update
June 6 2014
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109