Study Stopped
Early closure due to low accrual
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy
4 other identifiers
interventional
49
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jul 2004
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2004
CompletedFirst Posted
Study publicly available on registry
September 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
January 21, 2013
CompletedJanuary 28, 2021
January 1, 2013
3.8 years
September 7, 2004
November 30, 2012
January 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Resumption of Menses
Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years
Baseline, end of chemotherapy then 5 years
Secondary Outcomes (1)
Chemotherapy-related Amenorrhea
Baseline, end of chemotherapy then 5 years
Study Arms (2)
triptorelin
EXPERIMENTALGnRH analogue (triptorelin) during chemotherapy
no triptorelin
NO INTERVENTIONNo GnRH analogue (triptorelin) during chemotherapy
Interventions
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Eligibility Criteria
You may qualify if:
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Early-stage, operable disease
- Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer
- Hormone receptor status:
- Meets 1 of the following criteria:
- Estrogen receptor (ER)- OR progesterone receptor (PR)-positive
- ER- AND PR-negative
- No history of premature ovarian failure
- PATIENT CHARACTERISTICS:
- Age
- Under 45
- Sex
- Female
- Menopausal status
- +43 more criteria
You may not qualify if:
- History of premature ovarian failure
- Over 45 years of age
- First-degree relative menopausal at \< 40 years of age
- Pregnant or nursing
- Prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
- Known allergies to gonadotrophin-releasing hormone agonists
- Other cancer besides nonmelanoma skin cancer
- Prior chemotherapy
- Prior ovarian radiotherapy
- Prior bilateral oophorectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000, United States
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study closed to accrual early due to futility
Results Point of Contact
- Title
- Pamela Munster, MD
- Organization
- Division of Hematology & Oncology, University of California, San Francisco
Study Officials
- STUDY CHAIR
Pamela N. Munster, MD
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2004
First Posted
September 8, 2004
Study Start
July 1, 2004
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
January 28, 2021
Results First Posted
January 21, 2013
Record last verified: 2013-01