Adjuvant therapy in pre- and peri-menopausal patients with node negative breast cancer

International Breast Cancer Study Group0 个研究点目标入组 1,200 人开始时间: 1994年11月3日最近更新: 2020年1月13日

适应症

试验速览

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•Node negative disease• Patients must have had:a) Either total mastectomy or breast-conserving procedureb) Axillary clearance with at least 8 lymph nodes for pathological examinationc) The surgical procedure within 6 weeks prior to randomisation• At least 8 lymph nodes histo-pathologically examined• Tumour confirmed to breast with no detected metastases• Adequate marrow function• Documented evidence of adequate renal and hepatic function• Informed consent• Pre- and perimenopausal patients: a) > 52 years, and have had LNMP (last normal menstrual period) within 1 year; orb) < or equal to 52 years, and have had the LNMP within 3 years, or are currently menstruating; orc) < or equal to 55 years and have had hysterectomy without bilateral oophorectomy; ord) Biochemical confirmation of continuing ovarian function

•Axillary node involvement• Malignant breast tumours other than carcinoma• T4 tumours with ulceration or infiltration of the skin, peau d'orange, or metastatic disease• Bilateral malignancies, or mass in opposite breast, unless mass is proven by biopsy to be non-malignant• Patients who have had less than total mastectomy procedure in which margins of resection contained tumour cells, after which they did not subsequently undergo a total mastectomy • Pregnant at diagnosis or lactating patients (including those who have stopped lactating within past 6 months)• Previous or concurrent malignancy, except patients with squamous or basal cell carcinoma of skin, or adequately treated 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• Older than 45 years who have had a hysterectomy, unless there is chemical proof of ovarian function by all of the following tests: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), Oestradiol (E2) (Addendum 1 – 1/11/1991)• Estrogen receptor negative tumours or who are estrogen receptor status unknown (Addendum 7 - 1/08/1998)

发起方

International Breast Cancer Study Group