None listed
Conditions
Brief summary
This clinical trial is for post and perimenopausal women who after having surgery for their breast cancer are found to have tumours which are stimulated by oestrogens (‘oestrogen receptor positive’) and who have cancer present in the glands of the arm pits (‘positive axillary lymph nodes’). For this group of women it is not known whether the addition of chemotherapy to hormonal treatment is beneficial in reducing disease recurrence and improving survival. Patients on this trial will all receive a hormonal therapy for their breast cancer. Some patients will also receive chemotherapy either at the same time, or before their hormonal treatment. This will be determined by a process called randomisation which is similar to the toss of a coin. This trial assesses the optimal way of combining these treatments for this type of breast cancer.
Interventions
Patients will be randomised in equal proportions to the following treatment arms:
*Chemotherapy (4 cycles) + concurrent then subsequent Tamoxifen (20mg orally daily) for 5 years from randomisation
* Chemotherapy (4 cycles) + subsequent Tamoxifen (20mg orally daily) for 5 years from randomisation
* Tamoxifen (20mg orally daily) alone for 5 years
* Chemotherapy (4 cycles) + concurrent then subsequent Toremifene (60mg orally daily) for 5 years from randomisation
* Chemotherapy (4 cycles) + subse
Patients will be randomised in equal proportions to the following treatment arms: *Chemotherapy (4 cycles) + concurrent then subsequent Tamoxifen (20mg orally daily) for 5 years from randomisation * Chemotherapy (4 cycles) + subsequent Tamoxifen (20mg orally daily) for 5 years from randomisation * Tamoxifen (20mg orally daily) alone for 5 years * Chemotherapy (4 cycles) + concurrent then subsequent Toremifene (60mg orally daily) for 5 years from randomisation * Chemotherapy (4 cycles) + subsequent Toremifene (60mg orally daily) for 5 years from randomisation * Toremifene (60mg orally daily) alone for 5 years Chemotherapy: Doxorubicin 60mg/m2 (iv) and cyclophosphamide 600mg/m2 (iv) on day 1 of 21 day cycle OR Epirubicin 90mg/m2 (iv) and cyclophosphamide 600mg/m2 (iv) on day 1 of 21 day cycle
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
0 to 70 Years
Healthy volunteers
No
Inclusion criteria
Post/perimenopausal women - Patients with positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined)- Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, patients must have estrogen receptor positive tumours. (ER >= 10 fmol/mg cytosol protein or judged to be ER positive by immunohistochemical evaluation)- Patients must have had:a) Either total mastectomy or, optionally if the tumour was <= 5cm, a breast-conserving procedure (lumpectomy or quadrantectomy) b) Axillary clearance (not sampling) with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure within six weeks prior to randomisation- Minimum of eight lymph nodes histopathologically examined with at least one found positive- Tumour confined to the breast with no detected metastases - Adequate bone marrow function (WBC >= 4.0 x 10^9/L and platelets >+ 100 x 10^9/L)- Documented evidence of adequate renal function (creatinine < 120umol/L) and hepatic function (bilirubin <20umol/L, AST (SGOT) < 60 i.u./L)- Informed consent - Geographically accessible for follow-up
Exclusion criteria
Patients without axillary node involvement- Malignant breast tumours other than carcinoma- T4 carcinoma with ulceration, infiltration of the skin, peau d'orange or inflammatory breast cancer, or with distant metastases- Bilateral malignancies, or mass in opposite breast- Margins of resected specimen contained tumour cells- Estrogen-receptor negative tumours- Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or in situ carcinoma of cervix- Prior therapy for breast cancer- Other non-malignant systemic disease preventing treatment options or follow-up- Psychiatric or addictive disorders preventing informed consent- Bone scans showing hot spots which cannot be confirmed as benign disease
Outcome results
None listed