Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128778
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2005-08-09
Brief Title:
Maintenance Treatment With Liposomal Doxorubicin Caelyx in Metastatic Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase IVIII Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This is a randomized prospective and multicenter phase IV clinical trial which has been designed as a phase III study One hundred fifty-four women 77 per treatment arm will be recruited in the study
Detailed Description:
The main variable is time to disease progression All patients must be treated with first line of induction chemotherapy consisting of doxorubicin 75 mgm2 day 1 every 3 weeks and docetaxel 100 mgm2 day 1 every 3 weeks Both drugs must be administered sequentially Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel Otherwise patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel
Patients with complete response partial response or stable disease are eligible for 2001-01 study
The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10 46 months observation to 17 43 months Expected difference in mean time to progression is 6 97 months Hazard ratio 06 With an alpha error of 001 unilateral and power of 80 77 patients per arm are needed 154 patients in total
Patients with complete response partial response or stable disease are eligible for 2001-01 study
The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10 46 months observation to 17 43 months Expected difference in mean time to progression is 6 97 months Hazard ratio 06 With an alpha error of 001 unilateral and power of 80 77 patients per arm are needed 154 patients in total
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