Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01387373|
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : October 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Liver Metastases||Drug: oxaliplatin, capecitabine, trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||September 1, 2017|
Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine + trastuzumab systemic
Other Name: HAI
- Response rate [ Time Frame: 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
- Time to progression a) Intrahepatic progression b) Extrahepatic progression [ Time Frame: 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) [ Time Frame: 6 months after inclusion of last patient ]Total number of patients receiving RF treatment or surgical treatment
- Survival [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387373
|Herlev, Denmark, DK-2730|
|Principal Investigator:||Dorte Nielsen, Professor||professor|