NCT00196820

Mono Efficacy of Capecitabine (MoniCa)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine

Timeline

• Start date: 2005-07-01
• Completion: 2008-12-01
• First posted: 2005-09-20
• Last updated: 2011-10-06

Locations

1 site across 1 country: Germany