Randomised trial of high-dose epirubicin and cyclophosphamide x 3 supported by peripheral blood progenitor cells versus anthracycline and cyclophosphamide x 4 followed by cyclophosphamide, methotrexate, and 5-fluoruracil x 3 as adjuvant treatment for high risk operable stage II and stage III breast cancer in premenopausal and young postmenopausal (<=65 yrs) patients

International Breast Cancer Study Group0 个研究点目标入组 300 人开始时间: 1996年6月1日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

International Breast Cancer Study Group