Mono Efficacy of Capecitabine (MoniCa)

Breast Cancer Clinical Trial

Official title: A Multicenter Phase II Study to Determine the Efficacy of Capecitabine as First Line Monochemotherapy in Patients With HER2 Negative, Medium-risk, Metastatic Breast Cancer

Status Completed

Clinical Trial Summary

Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine

Clinical Trial Description

Study design:

Prospective, open phase II trial

Treatment:

Capecitabine 2000 mg/m² orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study

Primary objective

To determine the time to disease progression in patients with HER2 negative metastatic breast cancer after 1st line monochemotherapy with capecitabine

Secondary objectives

1. To determine the objective response rate

2. To determine the duration of response

3. To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks

4. To evaluate the safety and toxicity of capecitabine

5. To assess quality of life within 1 year after start of capecitabine treatment

6. To determine overall survival

7. To determine the objective response rate in male patients

8. To evaluate QoL the modified Brunner Score (Appendix 7 )

Tertiary objective

To determine the DPD and Proteomics in serum ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00196820
• Study type: Interventional
• Source: German Breast Group
• Status: Completed
• Phase: Phase 2
• Start date: July 2005
• Completion date: December 2008