Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
NCT00090844 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2021-01-28
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.
PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.
Conditions
- Breast Cancer
- Hormone Changes
- Drug Toxicity
Interventions
- DRUG
-
triptorelin
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of South Florida
lead OTHER
Principal Investigators
-
Pamela N. Munster, MD · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 44 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-07-31
- Primary Completion
- 2008-05-31
- Completion
- 2008-05-31
Countries
- United States
Study Locations
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