Endocrine treatment with letrozole, with or without local 3D conformal radiotherapy (3DCRT) of metastatic lesions in postmenopausal patients with inoperable, hormone-sensitive, oligometastatic breast cancer: a multicentre, randomised phase II study

Martin-Luther-University (Germany)0 个研究点目标入组 80 人开始时间: 2005年7月5日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Postmenopausal women with histologically or cytologically confirmed, oligometastatic breast cancer, defined as: =3 metastatic lesions, or primary tumor and =2 metastatic lesions not amenable to curative surgery for medical or surgical reasons
•2. No prior endocrine therapy for metastatic disease
•3. Estrogen receptor and/or progresterone receptor positive status or with both receptors unknown
•4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confined to the bones who may be included in case or non-measurable but assessable disease)
•5. Age >18 years, Eastern Cooperative Oncology Group (ECOG) 0-2
•6. Adequate hematological, renal and hepatic function

•1. Central nervous system (CNS) metastasis or other metastasis in anatomic proximity to peripheral nerves precluding the delivery of the planned radiotherapy
•2. Patients requiring immediate treatment with chemotherapy due to extensive visceral involvement or marked clinical symptoms
•3. Malignant ascites, pericardial or pleural effusions, malignant infiltration of the bone marrow
•4. Malabsorption syndrome or other uncontrolled medical conditions

发起方

Martin-Luther-University (Germany)