This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients without extrahepatic disease are included.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Oxaliplatin intrahepatic capecitabine + trastuzumab systemic
Herlev Hospital
Herlev, Denmark
Response rate
Number of patients with complete or partial response in the liver (RECIST version 1.1)Only patients with measurable disease are included in the protocol. Response rate number of patients with CR + PR divided with total number
Time frame: 6 months after inclusion of last patient
Time to progression a) Intrahepatic progression b) Extrahepatic progression
Time from treatment start to progression of disease or death of any cause.
Time frame: 6 months after inclusion of last patient
Number of patients suitable for local therapy (radiofrequency)
Total number of patients receiving RF treatment or surgical treatment
Time frame: 6 months after inclusion of last patient
Survival
All patients in intent-to-treat population , calculated from start of treatment to death of any cause
Time frame: 6 months after inclusion of last patient
Toxicity
All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.
Time frame: 28 days after last patient last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.