A phase III study to evaluate letrozole as adjuvant endocrine therapy for postmenopausal women with receptor (ER and/or PgR) positive tumours

ovartis Pharma AG, Basel0 个研究点目标入组 6,193 人开始时间: 2003年12月17日最近更新: 2020年1月13日

适应症

试验速览

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•Compliant postmenopausal women with histologically proven breast cancer who have had either a total mastectomy or a lesser procedure who are classified as pT1-3 or pT4b, Nx, Nsentinel-ve, N0-2, M0, and have oestrogen receptor and/or progesterone receptor positive tumours (ER/PR=10 fmol/mg cytosol protein or =10% of tumour cells positive by immunocytochemical assay); judged suitable for endocrine treatment; adequate marrow function, adequate renal and hepatic function; written and dated informed consent; geographically accessible for follow up; informed of data and material transfer and handling.

•Patients with distant metastases. Bilateral breast cancer except in situ lesions of the contralateral breast. Patients with prior ipsilateral in situ breast cancer. Patients with previous history of concomitant other (not breast) malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous malignancy must have been disease free for five years. Patients receiving adjuvant chemotherapy at randomisation. Patients with other non-malignant systemic diseases. Patients treated with systemic investigational drugs within the past 30 days or topical investigational drugs within the past 7 days. History of non-compliance to medical regimens and patients who are considered potentially unreliable. Patients known to be HIV positive.

发起方

ovartis Pharma AG, Basel