breastcancer with metastases MedDRA version: 16.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Dept of oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed concent Age > 18 years Performance status 0-1; expected survival > 3 months Prior treatment with a Taxane and antracyclin No treatment with capecitabine and oxaliplatin Evaluable disease (recist 1.1) neu granulocytes > 1,5, thrombocytes >100 bilirubine 30 ml/min 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate Number of patients with complete or partial respons (Recist 1.1);Secondary Objective: Time to a) Progression b) Survival c) Toxicity;Primary end point(s): Response rate Number of patients with complete or partial response. (RECIST version 1.1);Timepoint(s) of evaluation of this end point: After 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to progression Toxicity Overall survival;Timepoint(s) of evaluation of this end point: TTP: from first study drug administration to progression or death Survival:from first study drug administration to death of any cause Toxicity: at every clinical control | — |
Countries
Denmark
Contacts
Public ContactDept of oncology
Dept of oncology, Herlev Hospital
Outcome results
None listed