Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130507
Status:
TERMINATED
Last Update Posted:
2019-02-26
First Post:
2005-08-12
Brief Title:
Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Randomized Trial to Assess the Benefit of Adding Trastuzumab to Capecitabine and Vinorelbine as Second Line for HER2positive Breast Cancer Patients With Locally Advanced or Metastatic Disease Previously Treated With Trastuzumab and Taxanes
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A new alternative treatment caused the decrease in the rhythm of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eligible patients must receive vinorelbine plus capecitabine with or without trastuzumab until disease progression or unbearable toxicity Cycles will be administered every 3 weeksHuman epidermal growth factor receptor 2 HER2 status must be locally assessed by immunohistochemistry IHC All 3 patients are eligible In 2 patients HER2 status must be confirmed by fluorescence in situ hybridization FISH
Detailed Description:
Principal outcome is clinical benefit complete partial responses stable disease Sample size in each arm has been estimated with the Fleming method Previous data show a clinical benefit rate of vinorelbine plus capecitabine around 50 The researchers assume trastuzumab can increase it by 20 With an alpha error of 005 and 80 power 37 patients per arm are needed
This is a randomised phase II trial With a minimum expected benefit rate of 50 at least 36 patients are needed to choose with a 90 of probability to be right the best treatment arm providing it increases benefit rate at least by 15
Assuming a drop-out rate of 10 the total number of patients needed is 82 41 per treatment arm
Patients will be stratified as per investigational site and presence of visceral metastatic lesion liver lung pleura heart peritoneum suprarenal glands All patients must receive 2 cycles If no disease progression is detected treatment must continue until progression or unbearable toxicity
This is a randomised phase II trial With a minimum expected benefit rate of 50 at least 36 patients are needed to choose with a 90 of probability to be right the best treatment arm providing it increases benefit rate at least by 15
Assuming a drop-out rate of 10 the total number of patients needed is 82 41 per treatment arm
Patients will be stratified as per investigational site and presence of visceral metastatic lesion liver lung pleura heart peritoneum suprarenal glands All patients must receive 2 cycles If no disease progression is detected treatment must continue until progression or unbearable toxicity
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