Status:
UNKNOWN
Aromatase Inhibitor Clinical Trial
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsors:
Indiana University School of Medicine
Office of Research on Women's Health (ORWH)
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-70 years
Brief Summary
You are invited to participate in a research study looking at metabolism (breakdown) and effects of aromatase inhibitors. The purpose of this research is to try to identify which women who take an aro...
Detailed Description
Primary Objective To determine baseline breast density and the change in this parameter that occurs in post-menopausal women with hormone-receptor positive primary breast cancer taking letrozole or ex...
Eligibility Criteria
Inclusion
- Female gender.
- Post-menopausal status, defined as:
- age \> 60; or
- less than age 60 and the last menstrual period \>12 months prior to enrollment in trial if intact uterus/ovaries; or,
- less than age 60 and the last menstrual period 6-12 months prior to enrollment in trial if intact uterus/ovaries and meets biochemical criteria for menopause (FSH and estradiol levels within institutional standards for menopausal status) NOTE: These subjects will have serum estradiol levels checked at visits 0, 1, 3, 6 and 12 months to check for continued menopausal status; or,
- less than age 60 and history of bilateral oophorectomy; or,
- less than age 60 and has a history of hysterectomy and meets biochemical criteria for menopause (FSH and estradiol levels within institutional standards for menopausal status).
- NOTE: These subjects will have serum estradiol levels checked at visits 0, 1, 3, 6 and 12 months to check for continued menopausal status; or,
- less than age 60 and taking medication designed to suppress ovarian function and meets biochemical criteria for menopause (estradiol levels within institutional standards for menopausal status). Women would have had to be taking the drug for at least 30 days prior to entering the study.
- NOTE: While the patient is being treated with a GnRh agonist (luprolide or goserelin), serum estradiol levels will be checked at visits 0, 1, 3, 6 and 12 months to check for menopausal status.
- Patients with histologically proven ductal carcinoma in situ (DCIS/stage 0) or stage I-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are considering aromatase inhibitor therapy. Patients must have completed any adjuvant chemotherapy. Patients may have received preoperative chemotherapy. Patients should have also completed local therapy; however, enrollment/initiation of aromatase inhibitor on study may be done prior to completion of radiation therapy. Women may receive the aromatase inhibitor on this study as initial adjuvant hormonal treatment or following adjuvant tamoxifen.
- ECOG performance status 0-2.
- The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Exclusion
- History of bilateral mastectomy.
- History of radiation to the contralateral breast.
- Prior use of an aromatase inhibitor.
- Personal history of the following cancers: ovarian, endometrial, fallopian tube and primary peritoneal carcinomatosis.
- Presence of implant in contra-lateral breast.
- Women with history of breast reduction should be entered at the discretion of the investigator. Breast reduction during the two years of the trial is strongly discouraged.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00228956
Start Date
January 1 2005
End Date
February 1 2009
Last Update
September 25 2008
Active Locations (3)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21231
3
UMCCC
Ann Arbor, Michigan, United States, 48109