Metastatic Breast Cancer, Colon Cancer
Conditions
Brief summary
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.
Interventions
DRUGDocetaxel
DRUGXeloda
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Metastatic Breast Cancer: * women \>=18 years of age * Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. * Previous therapy should have included an anthracycline. * Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. * Female patients with histopathologically proven metastatic breast cancer * Adequate bone marrow, liver, renal and cardiac functions Colon Cancer: * Patients \>18 years of age * Patients with histologicaly confirmed colon cancer * Patients with potential curative tumor resection within 8 weeks before enrolment in the study * Patients previously not treated with chemiotherapy
Exclusion criteria
Metastatic Breast Cancer: * Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda) * Patients with contraindications for any of study drugs as listed in approved SmPC Colon Cancer: * Patients previously treated with chemiotherapy * Patients with contraindications for study drug as listed in approved SmPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | within 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS) | within 18 months |
Countries
Serbia
Outcome results
None listed