Safety of Xeloda in Solid Tumours

Completed

• Conditions: Metastatic Breast Cancer, Colon Cancer
• Interventions: Drug: Xeloda; Drug: Docetaxel

• 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

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

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

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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

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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