Liver Metastases, Metastatic Breast Cancer
Conditions
Keywords
breast cancer, metastatic, liver metastases, intrahepatic, chemotherapy
Brief 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 without extrahepatic disease are included.
Interventions
Oxaliplatin intrahepatic capecitabine + trastuzumab systemic
Sponsors
Dorte Nielsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 excluded 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months after inclusion of last patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression a) Intrahepatic progression b) Extrahepatic progression | 6 months after inclusion of last patient | Time from treatment start to progression of disease or death of any cause. |
| Number of patients suitable for local therapy (radiofrequency) | 6 months after inclusion of last patient | Total number of patients receiving RF treatment or surgical treatment |
| Survival | 6 months after inclusion of last patient | All patients in intent-to-treat population , calculated from start of treatment to death of any cause |
| Toxicity | 28 days after last patient last dose | All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used. |
Countries
Denmark
Outcome results
None listed