Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00196820
Brief 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
Study:
NCT00196820
Study Brief:
Protocol Section:
NCT00196820