IBCSG IX - Adjuvant therapy in postmenopausal patients with node negative breast cancer
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12607000029493
- Lead Sponsor
- International Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 900
Postmenopausal women who are:a) > 52 years, with at least 1 year amenorrhea; orb) < or equal to 52 years with 3 or more years of amenorrhea; or c) > 55 years and have had hysterectomy without bilateral oophorectomy; ord) Biochemical evidence of cessation of ovarian function (in questionable cases)Patients must have had:a. Either total mastectomy, or breast conserving procedure (lumpectomy or quadrantectomy)b. Axillary clearance with at least 8 lymph nodes for pathological examinationc. Surgical procedure within 6 weeks prior to randomisation• Node negative disease (without metastases detected at pathologic examination in at least 8 ipsilateral axillary nodes)• Eight lymph nodes histopathologically examined• Tumour confined to breast with no detected metastases• Adequate marrow function (WBC > 400/mm3 and platelets > 100,000/mm3• Documented evidence of adequate renal (creatinine < 120umol/l) and hepatic (bilirubin < 20umol/l, SGOT < 60 IU/l) function• Informed consent
• Axillary node involvement• Malignant breast tumours other than carcinoma• T4 tumours with ulceration or infiltration of skin, peau d' orange, or metastatic disease• Bilateral malignancies, or mass in opposite breast, unless mass is proven by biopsy to be non-malignant• Less than total mastectomy procedure in which margins of resection contained tumour cells, after which they did not subsequently undergo total mastectomy• Premenopausal patients• Previous or concurrent malignancy, except patients with squamous or basal cell carcinoma of skin, or in-situ carcinoma of cervix• Prior therapy for breast cancer, including irradiation, surgery, or chemo- and/or hormonal therapy• Other non-malignant systemic diseases preventing treatment options or prolonged follow-up• Psychiatric or addictive disorders preventing informed consent or treatment options• Bone scan showing hot spots which cannot be confirmed as benign disease, or skeletal pain of unknown cause• Estrogen receptor negative tumours or are oestrogen receptor status unknown (addendum 12).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) where all relapses, second primary tumours and deaths without recurrence are counted as failures.[Patients are assessed for disease status every 3 months during the first year on study, every 6 months during year 2 and annually thereafter for life.]
- Secondary Outcome Measures
Name Time Method Overall survival[Patients are assessed for survival, treatment-related side effects and systemic recurrence at each chemotherapy cycle administration, every 3 months during the first year on study, every 6 months during year 2 and annually thereafter for life.];Patterns of relapse[Patterns of relapse will be reviewed by the Data Safety and Monitoring Committee at semi-annual meetings.];Treatment-related side effects[Patients are assessed for survival, treatment-related side effects and systemic recurrence at each chemotherapy cycle administration, every 3 months during the first year on study, every 6 months during year 2 and annually thereafter for life.];Systemic disease-free survival[Will be monitored for the duration of the trial for possible early termination of patient entry.];Quality of Life[Quality of Life is assessed every 3 months during the first year on study, every 6 months during year 2 and annually until year 6.]