Clinical trial · Interventional
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer. A Phase II Trial
NCT01387373CI-TRIAL-00047474completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin, capecitabine, trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemotherapy
- interventionNames
- Drug: oxaliplatin, capecitabine, trastuzumab
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 6 months after inclusion of last patient
- description
- 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 outcomes (4)
- measure
- Time to progression a) Intrahepatic progression b) Extrahepatic progression
- timeFrame
- 6 months after inclusion of last patient
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.