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
triptorelin
Breast Diseases+4
+ Breast Neoplasms
+ Neoplasms
Supportive Care Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.49 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Until 44 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, United StatesMBCCOP - Medical College of Georgia Cancer Center
Augusta, United StatesMBCCOP - JHS Hospital of Cook County
Chicago, United States