Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003679
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Women With Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Comparative Trial of Adriamycin Taxotere vs Adriamycin Cyclophosphamide as Primary Medical Therapy for Patients With Potentially Operable Breast Cancer Greater Than or Equal to 3 cm Diameter Locally Advanced or Inflammatory Disease
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus cyclophosphamide for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of doxorubicin in combination with either docetaxel or cyclophosphamide in treating women who have previously untreated advanced or inflammatory breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of doxorubicin in combination with either docetaxel or cyclophosphamide in treating women who have previously untreated advanced or inflammatory breast cancer
Detailed Description:
OBJECTIVES I Compare the efficacy response rate and toxicity of doxorubicin in combination with either docetaxel or cyclophosphamide as primary therapy regimens in patients with locally advanced or inflammatory breast cancer
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center and operability Patients are randomized to one of two treatment arms Arm I Patients receive docetaxel IV followed by doxorubicin IV once every 3 weeks Arm II Patients receive doxorubicin IV and cyclophosphamide IV once every 3 weeks Patients receive a maximum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity Patients then undergo surgery if operable followed by more chemotherapy if node positive radiation therapy and oral tamoxifen for 5 years at the discretion of the investigator for estrogen receptor-negative patients Patients are followed at 12 18 and 24 months and then annually for at least 5 years
PROJECTED ACCRUAL A total of 350 patients 175 per arm will be accrued for this study
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center and operability Patients are randomized to one of two treatment arms Arm I Patients receive docetaxel IV followed by doxorubicin IV once every 3 weeks Arm II Patients receive doxorubicin IV and cyclophosphamide IV once every 3 weeks Patients receive a maximum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity Patients then undergo surgery if operable followed by more chemotherapy if node positive radiation therapy and oral tamoxifen for 5 years at the discretion of the investigator for estrogen receptor-negative patients Patients are followed at 12 18 and 24 months and then annually for at least 5 years
PROJECTED ACCRUAL A total of 350 patients 175 per arm will be accrued for this study
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 |
|---|---|---|---|
| EU-98053 | None | None | None |
| SCTN-BR9809 | None | None | None |