S9630, Medroxyprogesterone in Treating Women With Breast Cancer
NCT00002920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313
Last updated 2012-10-31
Summary
RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen.
PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.
Conditions
Interventions
- DRUG
-
medroxyprogesterone
- DRUG
-
tamoxifen citrate
- PROCEDURE
-
adjuvant therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Cancer and Leukemia Group B
collaborator NETWORK -
SWOG Cancer Research Network
lead NETWORK
Principal Investigators
-
Ronald K. Potkul, MD · Loyola University
-
Barbara L. Smith, MD, PhD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1997-03-31
- Primary Completion
- 2006-12-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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