Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
Condition: Metastatic Breast Cancer; Liver Metastases
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Liver Neoplasms
Intervention: oxaliplatin, capecitabine, trastuzumab
Intervention description: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Intervention MeSH terms: Capecitabine; Oxaliplatin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; liver metastases; intrahepatic chemotherapy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:• Informed consent

          -  Age > 18 years

          -  Performance status 0-1; expected survival ≥ 3 months

          -  Patient with histologically or cytologically confirmed locally advanced or metastatic
             adenocarcinoma of the breast

          -  Liver metastases not suitable for local treatment

          -  Extrahepatic disease should be determined by PET-CT-scan.

          -  No progression on treatment with capecitabine.

          -  Prior treatment with taxane (adjuvant or for metastatic disease)

          -  Metastases < 70 % of the liver

          -  Neutrophile granulocytes > 1.5 x 109/l og thrombocytes > 100 x 109/l

          -  Bilirubin < 2.0 x UNL (upper normal limit).

          -  Creatinine-clearance > 30 ml/min.

          -  INR < 1.6.

          -  If the patient is HER2-positive:Baseline LVEF ≥ 50 %

        Exclusion Criteria:

          -  History of chemotherapy within the 4-week period prior to the start of trial
             medication

          -  Other current or prior malignant disease except adequately treated and cured carcinoma
             in situ of the cervix or squamous cell carcinoma of the skin.

          -  Previous treatment with oxaliplatin

          -  Cytotoxic or experimental treatment within a 14 days period before start of trial
             medication

          -  The patient is not allowed to participate in other clinical trials.

          -  Any clinical symptoms suggesting peripheral neuropathy < or equal to grade 2 or CNS
             metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be
             performed within 4 weeks before inclusion

          -  Other severe medical conditions e.g. severe cardial disease or AMI < 1 year

          -  Presence of diseases which prevent oral therapy.

          -  Patients with uncontrolled infection

          -  Pregnant or lactating women

          -  Women capable of childbearing not using a sufficient non-hormonal method of birth
             control

          -  Patients not able to understand the treatment or to collaborate.

          -  Prior serious or unsuspected reaction after treatment with fluoropyrimidine

          -  Known prior hypersensitivity reactions to the agents

        If the patient is HER2-positive:

          -  Dyspnoea in due to complication related to malignant disease e.g.lung metastases with
             lymphangitis or other conditions with need of supportive oxygen.