Breast cancer patients with liver metastases (no extrahepatic disease) MedDRA version: 14.1 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: xeloda
Product Name: capecitabine
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Current Sponsor code: MA0919
Other descriptive name: mammaHAI
Concen
Sponsors
Herlev hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate Number of patients with complete or partial response in the liver (RECIST version 1.1) ;Secondary Objective: Time to a) Intrahepatic progression b) Extrahepatic progression c) Number of patients suitable for local therapy (radiofrequency) d) Survival e) Toxicity ;Primary end point(s): Response rate Number of patients with complete or partial response in the liver (RECIST version 1.1) | — |
Countries
Denmark
Outcome results
None listed