Fresolimumab and Radiotherapy in Metastatic Breast Cancer
This trial is active, not recruiting.
|Condition||metastatic breast cancer|
|Treatments||fresolimumab, radiation therapy|
|Sponsor||New York University School of Medicine|
|Collaborator||University of California, Los Angeles|
|Start date||July 2011|
|End date||June 2014|
|Trial size||24 participants|
|Trial identifier||NCT01401062, BC100481, S11-00533|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Abscopal response rate
time frame: up to 20 weeks
Male or female participants at least 18 years old.
- Biopsy-proven breast cancer, metastatic (persistent or recurrent).
- Failed ≥1 line of therapy (endocrine or chemotherapy) for metastatic disease.
- Min. 3 distinct metastatic sites, at least one measurable lesion which is at least 1
cm or larger in largest diameter.
- Must be ≥4 weeks since all of the following treatments (recovered from toxicity of
prior treatment to ≤Grade 1, excluding alopecia):
- major surgery;
- chemotherapy (≥6 weeks since therapy if a nitrosourea, mitomycin, or monoclonal
antibodies such as bevacizumab);
- biotherapy/targeted therapies.
- >18 years of age.
- Life expectancy >6 months.
- Eastern Cooperative Oncology Group (ECOG) status 0 or 1.
- Adequate organ function including:
- Hemoglobin ≥10.0g/dL, absolute neutrophil count (ANC) ≥1,500/mm3, and platelets
- Hepatic: Serum total bilirubin ≤1.5x upper limit of normal (ULN) (Patients with
Gilbert's Disease may be included if total bilirubin is ≤3.0mg/dL), alanine
aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5xULN. If
patient has known liver metastases, ALT and/or AST ≤5xULN are allowed.
- Renal: creatinine clearance ≥60mL/min.
- Prothrombin (PT) and partial thromboplastin times (PTT)
|Official title||Fresolimumab and Radiotherapy in Metastatic Breast Cancer|
|Principal investigator||Silvia Formenti, M.D.|
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