Safety of Xeloda in Solid Tumours
- Registration Number
- NCT02479217
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1268
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Monotherapy Xeloda Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer Adjuvant therapy Xeloda Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer Combination Therapy Xeloda Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression Combination Therapy Docetaxel Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events within 18 months
- Secondary Outcome Measures
Name Time Method Disease free survival (DFS) within 18 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which Xeloda exerts its anti-tumor effects in metastatic breast and colon cancer?
How does the combination of Xeloda with docetaxel compare to standard-of-care chemotherapy regimens in metastatic breast and colon cancer patients?
Which biomarkers are associated with improved safety and tolerability outcomes in patients receiving Xeloda as a single agent or in combination with docetaxel?
What are the most common adverse events reported in the Hoffmann-La Roche observational study of Xeloda in solid tumors (NCT02479217)?
Are there alternative combination therapies involving capecitabine (Xeloda) that demonstrate enhanced efficacy over docetaxel-based regimens in metastatic breast and colon cancer?