Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480597
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2007-05-30
Brief Title:
GemcitabineVinorelbine Versus GemcitabineCisplatin Versus GemcitabineCapecitabine in Metastatic Breast Cancer
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Randomised Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
Status:
COMPLETED
Status Verified Date:
2007-05
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:
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant adjuvant or palliative settings
For each randomisation arm 47 patients will be included The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective
Study Design
Arm A Gemcitabine 1000 mgm2 d1 8 Vinorelbine 25 mgm2 d1 8 q 3 weeks
Arm B Gemcitabine 1000 mgm2 d1 8 Cisplain 30 mgm2 d1 8 q 3 weeks
Arm C Gemcitabine 1000 mgm2 d1 8 Capecitabine 1650 mgm2 oral d1-14 q 3 weeks
For each randomisation arm 47 patients will be included The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective
Study Design
Arm A Gemcitabine 1000 mgm2 d1 8 Vinorelbine 25 mgm2 d1 8 q 3 weeks
Arm B Gemcitabine 1000 mgm2 d1 8 Cisplain 30 mgm2 d1 8 q 3 weeks
Arm C Gemcitabine 1000 mgm2 d1 8 Capecitabine 1650 mgm2 oral d1-14 q 3 weeks
Detailed Description:
None
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