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 with limited extrahepatic disease are included.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Oxaliplatin intrahepatic capecitabine and 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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions,
Time frame: up to 24 months from baseline
Number of Patients Suitable for Local Therapy (Radiofrequency)
Total number of patients receiving RF treatment or surgical treatment
Time frame: upon completion of treatment, an average of 7 months
Survival
All patients in intent-to-treat population , calculated from start of treatment to death of any course
Time frame: up to 7 years
Adverse Events
Number of participants with at least 1 AE related to study treatment - The details on which AEs occured are listed in the Adverse Event section below
Time frame: from start of treatment to 28 days after last treatment, an average of 7 months
PFS
From start of therapy to progression or death of any cause.
Time frame: up to 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.