Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190489
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2005-09-12
Brief Title:
A Trial of DoxorubicinCyclophosphamide AC Docetaxel D and Alternating AC and D for Metastatic Breast Cancer
Sponsor:
Japan Clinical Oncology Group
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Phase III Trial of Doxorubicin Cyclophosphamide AC Docetaxel D and Alternating AC and D AC-D as Front-line Chemotherapy for Metastatic Breast Cancer Japan Clinical Oncology Group Trial JCOG9802
Status:
COMPLETED
Status Verified Date:
2016-08
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:
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Detailed Description:
power to detect a 50 increase in median TTF at 0025 one-sided alpha in AC vs D and AC vs AC-D
Results 441pts 146 in AC 147 in D 148 in AC-D were randomized between 0199 and 0503 Major grade 3-4 toxicities were neutropenia 264546 for ACDAC-D febrile neutropenia 346 nauseavomiting 334 There was no toxic death One grade 4 diarrhea in AC-D and 1 secondary leukemia APL in D were reported Response CRPR rates were 30 41 and 35 for AC D and AC-D respectively Median TTF AC D and AC-D are 64 64 and 67 months p 255 for AC vs D p 275 for AC vs AC-D and median overall survival are 224 257 and 250 months p092 for AC vs D p076 for AC vs AC-D The same difference was shown by the adjusted Cox model
Conclusions No benefit was demonstrated in D and AC-D over AC in TTF however D and AC-D tended to be superior to AC in response rate and overall survival Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up
Results 441pts 146 in AC 147 in D 148 in AC-D were randomized between 0199 and 0503 Major grade 3-4 toxicities were neutropenia 264546 for ACDAC-D febrile neutropenia 346 nauseavomiting 334 There was no toxic death One grade 4 diarrhea in AC-D and 1 secondary leukemia APL in D were reported Response CRPR rates were 30 41 and 35 for AC D and AC-D respectively Median TTF AC D and AC-D are 64 64 and 67 months p 255 for AC vs D p 275 for AC vs AC-D and median overall survival are 224 257 and 250 months p092 for AC vs D p076 for AC vs AC-D The same difference was shown by the adjusted Cox model
Conclusions No benefit was demonstrated in D and AC-D over AC in TTF however D and AC-D tended to be superior to AC in response rate and overall survival Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up
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 |
|---|---|---|---|
| C000000179 | None | None | None |