A randomised, double-blind trial comparing Arimidex alone with Nolvadex alone with Arimidex and Nolvadex in combination, as adjuvant treatment in post-menopausal women with breast cancer.

AstraZeneca (formerly known as Zeneca, formerly known as ICI)0 个研究点目标入组 6,000 人开始时间: 1998年3月20日最近更新: 2020年1月13日

适应症

试验速览

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•Histologically proven operable invasive breast cancer. Patients who completed all primary surgery and chemotherapy and are candidates to receive hormonal adjuvant therapy. Post-menopausal women according to one or more of the following: a) aged 60 or > b) aged 45-59 and satisfying one or more of the following: i) amenorrhea for at least 12 months and intact uterus ii) amenorrhea < 12 months and FSH within post-menopausal range; including: Patients who have had hysterectomy. Patients who received HRT. Patients rendered amenorrhoeic by adjuvant chemotherapy iii) bilateral oophorectomy.

•Clinical evidence of metastatic disease. Patients unlikey to comply with trial requirements. Patients whose chemotherapy started > 8 weeks after completion of primary surgery or whose chemotherapy completed > 8 weeks before starting randomised treatment. Patients who have not received chemotherapy and whose primary surgery completed > 8 weeks before starting randomised treatment. Patients who received previous hormonal therapy as adjuvant treatment for breast cancer, unless: a) this was tamoxifen started prior to first surgical procedure and received < 29 days orb) this was hormonal therapy received pre-surgery in context of a formal trial, approved by Steering Committee. Patients who received tamoxifen as part of any breast cancer prevention trials, e.g. IBIS. Patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop. Previous history of invasive breast cancer or other invasive malignancy within last 10 years, other than squamous or basal cell carcinoma of skin or carcinoma in situ of cervix, adequately cone biopsied. Any severe concomitant disease placing patient at unusual risk or confound results of trial. Treatment with nonapproved or experimental drug 3 mths prior to randomisation. Patients at risk of transmitting any infection through blood or body fluids.

发起方

AstraZeneca (formerly known as Zeneca, formerly known as ICI)