A Clinical trial to Breast Cancer where two different ways to give the chemotherapy capsules are compared
Phase 1
- Conditions
- Patient with relapse of breast cancer will be randomised for two different chemotherapy regimes ( 2 treatments arms)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003564-72-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 110
Inclusion Criteria
Patients with relaps of breastcancer with WHO performance status equal to or under 2. Life time more than 16 weeks. age 18 years and older.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
Earlier treatment with Navelbine or Xeloda. Patients not able to swallow tablets.
CNS metastases.
Insufficient bone marrow or liver funktion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of an experimental chemotherapy arm, where Navelbine is given together with Xeloda in a metronomic manner to a standard treatment arm of Navelbine and Xeloda. We expect that the experimental arm is better than the standard treatment arm;Secondary Objective: To compare the toxicity and time to progression and overall survival of the two treatment arms.;Primary end point(s): To determine the response rate in the two treatment arms.<br>;Timepoint(s) of evaluation of this end point: Response after 3 cycles of chemotherapy will be evaluated
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time to progression and overall survival;Timepoint(s) of evaluation of this end point: Patients will be followed to death of dissease.