Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201708
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2005-09-12
Brief Title:
Dose-Dense Docetaxel Before or After DoxorubicinCyclophosphamide in Axillary Node-Positive Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After DoxorubicinCyclophosphamide AC in Axillary Node-Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-09
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 study will determine if docetaxel will be administered before or after doxorubicincyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial
Detailed Description:
Rationale Studies suggest that chemotherapy agents docetaxel doxorubicin and cyclophosphamide have some efficacy against different types of breast cancer However the optimal sequence in which to administer these treatments remains unknown The current study assesses two separate sequences of docetaxel doxorubicin and cyclophosphamide
Purpose This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer Combination one is docetaxel before doxorubicin and cyclophosphamide Combination two is docetaxel after doxorubicin and cyclophosphamide The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study The toxicities of docetaxel will also be assessed in study participants
Treatment Patients in this study will receive one of two chemotherapy combination schedules A computer will randomly assign patients into their treatment group Group one will receive docetaxel before doxorubicin and cyclophosphamide Group two will receive docetaxel after doxorubicin and cyclophosphamide
Patients in group one will receive docetaxel every two weeks for a total of eight weeks These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks These patients will then be given docetaxel every two weeks for a total of eight weeks
Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
Purpose This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer Combination one is docetaxel before doxorubicin and cyclophosphamide Combination two is docetaxel after doxorubicin and cyclophosphamide The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study The toxicities of docetaxel will also be assessed in study participants
Treatment Patients in this study will receive one of two chemotherapy combination schedules A computer will randomly assign patients into their treatment group Group one will receive docetaxel before doxorubicin and cyclophosphamide Group two will receive docetaxel after doxorubicin and cyclophosphamide
Patients in group one will receive docetaxel every two weeks for a total of eight weeks These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks These patients will then be given docetaxel every two weeks for a total of eight weeks
Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
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