Intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tu,our in combination with trastuzumab (Herceptin (R)) in patientswith non-resectable liver metasatses from breast cancerA phase II trial in patients without extrahepatic disease.

Phase 1

• Conditions: Breast cancer patients with liver metastases (no extrahepatic disease); MedDRA version: 14.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-014863-37-DK
• Lead Sponsor: Herlev hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-20
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Informed consent
•Age > 18 years
•Performance status 0-1; expected survival = 3 months
•Patient with histologically or cytologically confirmed 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)
•Metastatic involvement < 70 % of the liver
•Neutrophil granulocytes ? 1.5 x 109/l and thrombocytes ? 100 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit)
•Creatinine-clearence ? 30 ml/min
•INR < 2
•An angiography shows that intrahepatic treatment can be accomplished
•The treatment is approved by ”Second Opinion udvalget”

If the patient is HER2-positive:
•Baseline LVEF = 50 % (MUGA or echocardiography)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
•Current participation in other clinical trials
•Any clinical symptoms suggesting peripheral neuropathy grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan must be conducted within 4 weeks before inclusion)
•Other severe medical conditions e.g. severe cardiovascular disease or AMI < 1 year
•Medical diseases or condition affecting the patients compliance with peroral study drug
•Patients with uncontrolled infection
•Pregnant or lactating women
•Women capable of childbearing not using a sufficient non-hormonal method of birth control (spiral)
•Patients who due to physiological, intelectual, cultural reasons, or lack of language capabilities, an unable to comply with the treatment concept or to place the patient at high risk from treatment related complications
•Prior serious or unsuspected reaction to fluorpyrimidin therapy
•Known prior hypersensitivity reactions any components used
If the patient is HER2-positive:
•Dyspnoe at rest due to complication of advanced malignancy e.g.lung metastases with lymphangitis or any other conditions necessitating supportive oxygen therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified