Phase II Randomized Study of Triptorelin for Preserving Ovarian Function in Premenopausal Women With Early-Stage Operable Breast Cancer Undergoing Adjuvant or Neoadjuvant Systemic Chemotherapy
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Supportive care
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Completed
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Under 45
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NCI
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MCC-0203 NCI-7031, NCT00090844, 7031, HLMCC 0203
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - See Disease Characteristics
- No prior chemotherapy
Endocrine therapy - At least 2 weeks since prior oral contraceptives
- No prior fertility treatment
- Clomiphen 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
Patient Characteristics:
Age Sex 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 Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment 138A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months. Outcomes Primary Outcome(s)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
Secondary Outcome(s)Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment Alternative markers of ovarian failure as assessed by inhibin A and inhibin B every 6 months beginning in month 6 for 2 years and then annually for 3 years Quality of life as assessed by FACT-ES monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years Disease-free survival every very 6 months beginning in month 6 for 2 years and then annually for 3 years
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 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.
Trial Contact Information
Trial Lead Organizations H. Lee Moffitt Cancer Center CCOP Research Base ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Pamela Munster, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) |
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | Preservation of Ovarian Function in Young Women Treated with (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the GnRH Agonist (Triptorelin) During Chemotherapy | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2004-07-14 | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2008-05-28 | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00090844 | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2004-06-07 | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2007-01-18 | ![](https://webarchive.library.unt.edu/eot2008/20081020105736im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA76292 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |