None listed
Conditions
Brief summary
This clinical trial is for premenopausal and young postmenopausal women who after their breast cancer surgery have been found to have cancer cells in the glands of the armpit (‘positive axillary lymph nodes’) and whose tumours do not have oestrogen receptors (are not stimulated by oestrogen). These tumour characteristics are often associated with a higher risk for breast cancer recurrence. It is known that chemotherapy in standard doses after breast cancer surgery reduces the chance of breast cancer recurrence. However, this clinical trial aims to assess whether giving higher doses of chemotherapy is more effective in killing remaining cancer cells in women with a high risk of recurrence. Women will be allocated randomly (like the toss of a coin) to have either standard chemotherapy for their breast cancer, or high dose chemotherapy.
Interventions
Arm B: Filgrastim (10ug/kg subcutaneously daily) for 6 days with leukapheresis on days 5-7. This is followed by 3 cycles (cycle =21 days) Epirubicin (200mg/m^2 iv over 12 hours on day 1), cyclophosphamide (4gm/m^2 iv as 4 divided doses – day 2), MESNA (7.2gm/m^2 – days 2 & 3), Peripheral Blood Progenitor Cell (PBPC) infusion (day 5) and Filgrastim (5ug/kg daily subcutaneously – from day 6 until White Blood Cells>10 x 10^9/l). Tamoxifen (20mg orally daily) then follows for 5 years.
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
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Histologically proven breast cancer• Primary tumour must be classified as T1a,b,c, T2 or T3, N1 or N2, M0• Patients must be categorized as at least one of the following:a) >/= 10 involved axillary nodesb) >/= 5 involved axillary nodes and primary tumour that is ER-negativec) >/= 5 involved axillary nodes and T3 tumour who had breast cancer surgical procedure (irrespective of ER status)• Attempts should be made to determine estrogen receptor status of tumour• Patients must have had:a) Either total mastectomy or breast-conserving procedure (lumpectomy or quadrantectomy) for T1, T2 or T3 tumours.b) Primary breast cancer surgical procedure must be within six weeks prior to randomization• Tumour must be confined to breast and axillary lymph nodes. All nodes must be examined by pathologist• Left ventricular ejection fraction greater than 50% by resting MUGA radionuclide scan• Adequate marrow function (WBC >/= 4.0 x 10^9/l and platelet count >/= 100 x 10^9/l)• Adequate renal function (serum creatinine </= 120 mmol/l) and hepatic function (bilirubin </= 20 umol/l, AST (SGOT) </= 2 times the upper limit of normal)• Informed consent• Geographically accessible for follow-up• ECOG performance status 0-2.
Exclusion criteria
• Malignant tumours other than carcinoma• Locally inoperable breast cancer as defined by following:a) satellite skin nodules distant to primary tumourb) supraclavicular node involvementc) inoperable, matted axillary nodesd) primary tumour fixed to the chest wall, excluding pectoralis major• Distant metastases• Bilateral malignancies, or mass in opposite breast• Other malignancies except basal cell carcinoma or carcinoma in situ of cervix• Non-malignant disease preventing treatment options or prolonged follow-up• Prior therapy for breast cancer• Pregnant or lactating women• Psychiatric, addictive or any disorder preventing informed consent• Bone scan showing hot spots which cannot be confirmed as benign disease.
Outcome results
None listed