Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003352
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin Doxorubicin Taxotere Docetaxel and Cyclophosphamide ATC
Status:
COMPLETED
Status Verified Date:
2012-12
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:
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin cyclophosphamide and docetaxel in treating women with stage IIIB or stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin cyclophosphamide and docetaxel in treating women with stage IIIB or stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the overall response rate to doxorubicin docetaxel and cyclophosphamide ATC in women with metastatic or locally advanced breast cancer II Determine survival time to first response time to progression and duration of response in these patients III Evaluate the feasibility of administering ATC for at least 4 courses IV Evaluate the toxicity profile of ATC and its effect on cardiac function
OUTLINE Patients receive intravenous doxorubicin over 15 minutes on day 0 followed by intravenous cyclophosphamide over 30 minutes An hour after the end of the doxorubicin infusion intravenous docetaxel is administered over 1 hour Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed When the maximum dose of doxorubicin is reached treatment continues with docetaxel and cyclophosphamide Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response Patients are followed every 6 weeks
PROJECTED ACCRUAL Approximately 89 patients will be accrued to this study within 14 months
OUTLINE Patients receive intravenous doxorubicin over 15 minutes on day 0 followed by intravenous cyclophosphamide over 30 minutes An hour after the end of the doxorubicin infusion intravenous docetaxel is administered over 1 hour Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed When the maximum dose of doxorubicin is reached treatment continues with docetaxel and cyclophosphamide Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response Patients are followed every 6 weeks
PROJECTED ACCRUAL Approximately 89 patients will be accrued to this study within 14 months
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 |
|---|---|---|---|
| NSABP-BP-58 | None | None | None |