Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital

May 31, 2011
July 4, 2011
March 21, 2014
April 2010
December 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01387295 on Archive Site
  • 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.
Same as current
Not Provided
Not Provided
Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
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

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.

Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Metastatic Breast Cancer
  • Liver Metastases
Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Other Name: HAI
Experimental: chemotherapy
Intervention: Drug: oxaliplatin, capecitabine, trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2014
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
MA 0918
Not Provided
Not Provided
Dorte Nielsen, Herlev Hospital
Dorte Nielsen
Not Provided
Principal Investigator: Dorte Nielsen, Professor professor
Herlev Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP