Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
|ClinicalTrials.gov Identifier: NCT01387295|
Recruitment Status : Unknown
Verified June 2013 by Dorte Nielsen, Herlev Hospital.
Recruitment status was: Recruiting
First Posted : July 4, 2011
Last Update Posted : March 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Liver Metastases||Drug: oxaliplatin, capecitabine, trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 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 in Patients With Limited Extrahepatic Disease|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Other Name: HAI
- Response rate [ Time Frame: 6 months after last patient included ]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
- Number of patients suitable for local therapy (radiofrequency) [ Time Frame: 6 months after last patient included ]Total number of patients receiving RF treatment or surgical treatment
- Survival [ Time Frame: 6 months after last patient included ]All patients in intent-to-treat population , calculated from start of treatment to death of any course
- toxicity [ Time Frame: 28 days after last treatment of last patient ]All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.
- PFS [ Time Frame: 6 months after last patient included ]From start of therapy to progression or death of any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387295
|Contact: Dorte Nielsen, Professor||+4544884000 ext firstname.lastname@example.org|
|Contact: Birgitte Krogh Jensen, Study nurse||+4544884000 ext email@example.com|
|Herlev, Denmark, DK-2730|
|Contact: Dorte Nielsen, Professor +4544884000 ext 82344 firstname.lastname@example.org|
|Contact: Birgitte Krogh Jensen, Study nurse +454488000 ext 89562 email@example.com|
|Principal Investigator: Dorte Nielsen, professor|
|Principal Investigator:||Dorte Nielsen, Professor||professor|