Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002707
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A RANDOMIZED TRIAL COMPARING PREOPERATIVE DOXORUBICIN ADRIAMYCINCYCLOPHOSPHAMIDE AC TO PREOPERATIVE AC FOLLOWED BY PREOPERATIVE DOCETAXEL TAXOTERE AND TO PREOPERATIVE AC FOLLOWED BY POSTOPERATIVE DOCETAXEL IN PATIENTS WITH OPERABLE CARCINOMA OF THE BREAST
Status:
COMPLETED
Status Verified Date:
2010-02
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 It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Compare overall and disease-free survival in patients with operable adenocarcinoma of the breast treated with 4 courses of preoperative doxorubicin and cyclophosphamide AC alone vs 4 courses of preoperative or postoperative docetaxel TXT following 4 courses of preoperative AC II Evaluate whether the addition of preoperative TXT to preoperative AC results in improved rates of clinical and pathologic locoregional tumor response III Assess whether the addition of preoperative TXT to preoperative AC results in improved rates of breast conservation IV Assess whether postoperative TXT improves disease-free and overall survival in patients who receive preoperative AC especially in certain subgroups of patients eg those with pathologically positive nodes
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over clinical tumor size less than 21 cm vs 21-40 cm vs greater than 40 cm clinical nodal status negative vs positive and participating center Patients are randomized to one of three treatment arms Arm I Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses Patients receive oral tamoxifen daily for 5 years starting on day 1 After completion of chemotherapy patients are offered surgery eg lumpectomy with axillary node dissection or modified radical mastectomy Post-operative radiotherapy is given post-lumpectomy Arm II Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours followed by docetaxel IV over 1 hour on day 1 once every 21 days for 4 courses Patients receive oral tamoxifen daily for 5 years starting on day 1 After the completion of chemotherapy surgery is offered as in arm I Radiotherapy follows surgery in post-lumpectomy patients Arm III Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses Patients receive oral tamoxifen daily for 5 years starting on day 1 After completion of chemotherapy surgery is offered as in arm I After surgical recovery docetaxel IV is given over 1 hour once every 21 days for 4 courses Radiotherapy follows docetaxel in post-lumpectomy patients Chemotherapy is repeated every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 2400 patients will be accrued for this study within 5 years
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over clinical tumor size less than 21 cm vs 21-40 cm vs greater than 40 cm clinical nodal status negative vs positive and participating center Patients are randomized to one of three treatment arms Arm I Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses Patients receive oral tamoxifen daily for 5 years starting on day 1 After completion of chemotherapy patients are offered surgery eg lumpectomy with axillary node dissection or modified radical mastectomy Post-operative radiotherapy is given post-lumpectomy Arm II Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours followed by docetaxel IV over 1 hour on day 1 once every 21 days for 4 courses Patients receive oral tamoxifen daily for 5 years starting on day 1 After the completion of chemotherapy surgery is offered as in arm I Radiotherapy follows surgery in post-lumpectomy patients Arm III Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses Patients receive oral tamoxifen daily for 5 years starting on day 1 After completion of chemotherapy surgery is offered as in arm I After surgical recovery docetaxel IV is given over 1 hour once every 21 days for 4 courses Radiotherapy follows docetaxel in post-lumpectomy patients Chemotherapy is repeated every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 2400 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| CDR0000064521 | None | None | None |