Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
- Conditions
- InfertilityMenopausal SymptomsBreast Cancer
- Registration Number
- NCT00427245
- Lead Sponsor
- Anglo Celtic Cooperative Oncology Group
- Brief Summary
RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .
Secondary
* Compare the quality of life of patients treated with these regimens.
* Compare menopausal symptoms in patients treated with these regimens.
* Compare bone mineral density loss in patients treated with these regimens.
* Compare hormone levels in patients treated with these regimens.
* Compare menstruation in patients treated with these regimens.
* Compare the incidence of pregnancy in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study. Patients are stratified according to age (≤ 40 years vs \> 40 years) and participating center. Patients are randomized to 1 of 2 treatment arms.
Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity.
Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy. Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.
Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually for up to 5 years.
After completion of study therapy, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
- Secondary Outcome Measures
Name Time Method Incidence of menopausal symptoms Quality of life Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers Incidence of pregnancy Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
Trial Locations
- Locations (66)
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Frenchay Hospital
🇬🇧Bristol, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Halton Hospital
🇬🇧Cheshire, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
Scroll for more (56 remaining)Basingstoke and North Hampshire NHS Foundation Trust🇬🇧Basingstoke, England, United Kingdom