Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

• ClinicalTrials.gov Identifier: NCT01387373
• Recruitment Status: Completed
• First Posted: July 4, 2011
• Last Update Posted: October 5, 2020
• Sponsor: Dorte Nielsen
• Information provided by (Responsible Party): Dorte Nielsen, Herlev Hospital

Study Description

Brief Summary:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• 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
• Study Start Date: April 2010
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: September 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: chemotherapy	Drug: oxaliplatin, capecitabine, trastuzumab; Oxaliplatin intrahepatic capecitabine + trastuzumab systemic; Other Name: HAI

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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
3. 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
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Denmark

Herlev Hospital

Herlev, Denmark, DK-2730

Sponsors and Collaborators

Dorte Nielsen

Investigators

• 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
• ClinicalTrials.gov Identifier: NCT01387373
• Other Study ID Numbers: MA 0919
• First Posted: July 4, 2011
• Last Update Posted: October 5, 2020
• Last Verified: October 2020

Keywords provided by Dorte Nielsen, Herlev Hospital:

breast cancer; metastatic; liver metastases; intrahepatic; chemotherapy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Liver Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Neoplastic Processes; Pathologic Processes; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Capecitabine; Oxaliplatin; Trastuzumab; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological