Status:
TERMINATED
Pharmacogenetics as a Predictor of Toxicity in Pre-Menopausal Women Receiving Doxorubicin and Cyclophosphamide in Early Breast Cancer
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-45 years
Brief Summary
The goal of this pilot study is to delineate the role of genetic variations in premature menopause, hot flashes, and other toxicities in a cohort of premenopausal women with early breast cancer. Prim...
Detailed Description
There is a clear survival benefit with the use of adjuvant cytotoxic therapy for most women with invasive breast cancer, even in those who have hormone receptor positive disease and receive adjuvant h...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the breast and appropriate for treatment with Doxorubicin and Cyclophosphamide.
- Age \> 18 years and \<45 years.
- ECOG performance status of 0 to 2.
- Signed informed consent.
- Premenopausal: defined as regularly occurring menstrual cycles or serologic estradiol and FSH levels consistent with premenopausal status.
Exclusion
- Patients with distant metastatic disease will be excluded.
- Pregnancy or breast feeding (women of childbearing potential must have a negative pregnancy test). Women of childbearing potential must be willing to consent to using effective contraception (oral contraceptive pill or implant or barrier method) while on treatment and for a 30 days after taking the last dose of chemotherapy.
- Male sex will be excluded.
- Use of agent designed to suppress ovarian function (i.e. LHRH agonist).
- Use of exogenous estrogen (hormone replacement therapy) will be prohibited with the exception of topical vaginal preparations (as deemed necessary by the treating physician) and oral contraceptives.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 13 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00352872
Start Date
February 1 2005
End Date
January 13 2009
Last Update
March 2 2018
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202