Status:
TERMINATED
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hormone Changes
Eligibility:
FEMALE
Up to 44 years
Phase:
PHASE2
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...
Detailed Description
OBJECTIVES: Primary * Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breas...
Eligibility Criteria
Inclusion
- 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
- Premenopausal
- Follicle-stimulating hormone levels \< 40 IU/L at baseline AND at least 2 menstrual periods within the past 6 months
- No first-degree relative menopausal at \< 40 years of age
- Performance status
- Eastern Cooperative Oncology Group \[ECOG\] 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Fertile patients must use effective non-hormonal methods of contraception
- No prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
- No known allergies to gonadotrophin-releasing hormone agonists
- No other cancer except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- No prior chemotherapy
- Endocrine therapy
- At least 2 weeks since prior oral contraceptives
- No prior fertility treatment
- Clomiphene or pergonal for polycystic ovarian disease allowed
- No other concurrent oral or transdermal hormonal therapy, including any of the following:
- Estrogen
- Progesterone
- Androgens
- Aromatase inhibitors
- Hormone replacement therapy
- Oral contraceptives
- Radiotherapy
- No prior ovarian radiotherapy
- Surgery
- No prior bilateral oophorectomy
- No plans for oophorectomy or hysterectomy within the next 2 years
- Other
- At least 1 week since prior warfarin
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00090844
Start Date
July 1 2004
End Date
May 1 2008
Last Update
January 28 2021
Active Locations (9)
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1
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
2
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
3
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
4
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States, 60612