Status:
COMPLETED
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
Anglo Celtic Cooperative Oncology Group
Conditions:
Breast Cancer
Infertility
Eligibility:
FEMALE
Phase:
PHASE3
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 u...
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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stages I-IIIB with node-positive or -negative disease (N0-2)
- Operable disease
- Must meet 1 of the following criteria:
- Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
- Scheduled to receive neoadjuvant chemotherapy
- No metastatic breast cancer, including supraclavicular fossa metastases
- Hormone receptor status meeting 1 of the following criteria:
- Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
- ER positive AND no requirement for ovarian suppression as a necessary part of treatment
- PATIENT CHARACTERISTICS:
- Female
- Premenopausal with regular menses in the 12 months preceding surgery
- No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Suitable fitness status for chemotherapy
- Adequate hepatic, renal, and bone marrow function
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or endocrine therapy
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00427245
Start Date
August 1 2004
Last Update
August 7 2013
Active Locations (66)
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1
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
2
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
3
Frenchay Hospital
Bristol, England, United Kingdom, BS16 1LE
4
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ