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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Dorte Nielsen, Herlev Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital Identifier:
First received: May 31, 2011
Last updated: March 20, 2014
Last verified: June 2013

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 Intervention Phase
Metastatic Breast Cancer Liver Metastases Drug: oxaliplatin, capecitabine, trastuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Dorte Nielsen, Herlev Hospital:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Other Name: HAI


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01387295

Contact: Dorte Nielsen, Professor +4544884000 ext 82344
Contact: Birgitte Krogh Jensen, Study nurse +4544884000 ext 89562

Herlev Hospital Recruiting
Herlev, Denmark, DK-2730
Contact: Dorte Nielsen, Professor    +4544884000 ext 82344   
Contact: Birgitte Krogh Jensen, Study nurse    +454488000 ext 89562   
Principal Investigator: Dorte Nielsen, professor         
Sponsors and Collaborators
Dorte Nielsen
Principal Investigator: Dorte Nielsen, Professor professor
  More Information

Responsible Party: Dorte Nielsen, Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital., Herlev Hospital Identifier: NCT01387295     History of Changes
Other Study ID Numbers: MA 0918
Study First Received: May 31, 2011
Last Updated: March 20, 2014

Keywords provided by Dorte Nielsen, Herlev Hospital:
breast cancer
liver metastases
intrahepatic chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on September 21, 2017