Breast Cancer Clinical Trial
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
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.
Full 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 breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.
Secondary
Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug.
Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug.
Determine quality of life of patients treated with this drug.
Determine disease-free and overall survival of patients treated with this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (< 35 years vs 35 to 39 years vs > 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide [6 courses] OR fluorouracil, doxorubicin, and cyclophosphamide [6 courses] vs doxorubicin and cyclophosphamide [AC] [4 courses] vs doxorubicin and cyclophosphamide [AC] [4 courses] followed by a taxane [4 courses]); and hormone receptor status (estrogen receptor [ER]- AND progesterone receptor [PR]-negative vs ER- OR PR-positive).
Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy.
Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years.
Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.
Eligibility Criteria
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
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There are 8 Locations for this study
Oakland California, 94609, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60612, United States
Springfield Missouri, 65807, United States
Springfield Missouri, 65807, United States
Fargo North Dakota, 58122, United States
Temple Texas, 76508, United States
Tacoma Washington, 98405, United States
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