Safety of Xeloda in Solid Tumours

Roche

Status: Completed

Conditions: Metastatic Breast Cancer, Colon Cancer

Treatments: Drug: Docetaxel; Drug: Xeloda

Study type: Observational

Funder types: Industry

Identifiers

NCT02479217

ML20367

Details and patient eligibility

About

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.

Enrollment: 1,268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,268 participants in 3 patient groups

Adjuvant therapy

Description:

Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer

Treatment:

Drug: Xeloda

Combination Therapy

Description:

Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression

Treatment:

Drug: Xeloda

Drug: Docetaxel

Monotherapy

Description:

Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer

Treatment:

Drug: Xeloda