Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196820
Status:
COMPLETED
Last Update Posted:
2011-10-06
First Post:
2005-09-12
Brief Title:
Mono Efficacy of Capecitabine MoniCa
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
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
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm² orally day 1-14 q day 22 until progression unacceptable toxicity patients 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
Prospective open phase II trial
Treatment
Capecitabine 2000 mgm² orally day 1-14 q day 22 until progression unacceptable toxicity patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract Number 2005-000074-51 | None | None | None |