None listed
Conditions
Brief summary
This randomised clinical trial will compare the combination of three cycles of chemotherapy (CMF) followed by tamoxifen versus tamoxifen alone in postmenopausal patients with node negative, oestrogen receptor positive breast cancer to determine which therapeutic strategy is better in terms of disease-free survival, overall survival and quality of life.
Interventions
Arm B: CMF (cyclophosphamide 100mg /m^2 orally days 1-14, Methotrexate i.v. 40mg/m^2 days 1 and 8 and 5-Fluorouracil i.v. 600mg/m^2 days 1 and 8) for three cycles (cycle duration is 28 days) followed by Tamoxifen (20mg orally daily for 57months – addendum 3). Combined this gives a total duration of treatment of 60 months.
Sponsors
International Breast Cancer Study Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
• 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).
Outcome results
None listed