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

Completed

Conditions: Malignant neoplasm of breast
Cancer
Inoperable, hormone-responsive, oligometastatic breast cancer

Registration Number: ISRCTN15692114

Lead Sponsor: Martin-Luther-University (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival as measured by the one-year progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
1. Objective tumor response rate<br>2. Toxicity<br>3. 1-, 2-, 3-year survival rates<br>4. Clinical benefit (defined as proportion of patients with stable disease [SD] >24 weeks, complete response [CR] and partial response [PR])<br>5. Quality of life, as measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) C30 and BR-23