Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer TGF-beta fresolimumab monoclonal antibody radiation therapy abscopal response
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.

Detailed description:

Arms:
arm 1: Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2). arm 2: Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Interventions: intervention 1: Fresolimumab intervention 2: Radiation Therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: