Breast Cancer Clinical Trial
Official title:
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
Verified date | January 2013 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 49 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 44 Years |
Eligibility | Inclusion Criteria: 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | MBCCOP - JHS Hospital of Cook County | Chicago | Illinois |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | CCOP - Northwest | Tacoma | Washington |
United States | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida |
United States | CCOP - Scott and White Hospital | Temple | Texas |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Chemotherapy-related Amenorrhea | Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years. | Baseline, end of chemotherapy then 5 years |
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