Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
|ClinicalTrials.gov Identifier: NCT00427245|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Infertility Menopausal Symptoms||Drug: cyclophosphamide Drug: goserelin acetate Procedure: adjuvant therapy Procedure: fertility assessment and management Procedure: neoadjuvant therapy||Phase 3|
- Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]|
|Study Start Date :||August 2004|
- Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
- 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
- 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
- Incidence of pregnancy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427245
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|Study Chair:||Robert C.F. Leonard, MD, BS, MB||Charing Cross Hospital|