Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004067
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
1999-12-10
Brief Title:
Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol AC-T to That of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin AC-TH in Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2
Status:
COMPLETED
Status Verified Date:
2021-04
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 such as doxorubicin cyclophosphamide and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer
PURPOSE This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2
PURPOSE This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2
Detailed Description:
OBJECTIVES
Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab Herceptin in women with operable node-positive breast cancer that overexpresses HER2
Compare the effect of these regimens on disease-free and overall survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive nodes 1-3 vs 4-9 vs 10 or more administration of hormonal therapy tamoxifen vs anastrozole vs neither surgeryradiotherapy lumpectomy plus breast irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy without radiotherapy vs mastectomy with radiotherapy paclitaxel schedule every 3 weeks vs weekly and participating center Patients are randomized to one of two treatment arms
Arm 1 Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses Approximately 3 weeks after the last course patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR paclitaxel IV over 1 hour once weekly for 12 weeks 12 doses
Arm 2 Patients receive chemotherapy as in arm I and trastuzumab Herceptin IV over 90 minutes on day 1 of the first course of paclitaxel Trastuzumab is then administered IV over 30 minutes weekly for 51 weeks beginning on day 8
All patients with estrogen or progesterone receptor-positive tumors receive hormonal therapy for at least 5 years beginning within 3-12 weeks after the last dose of chemotherapy Patients who have received prior tamoxifen for prevention may be treated with additional tamoxifen for no more than 5 years at the discretion of the principal investigator PI
NOTE Other hormonal therapeutic agents are allowed in sequence with or as an alternative to tamoxifen therapy
All patients previously treated with lumpectomy undergo breast irradiation beginning after completion of chemotherapy and concurrently with trastuzumab in arm 2 administration Patients previously treated with mastectomy may also receive radiotherapy Radiotherapy is administered daily for 5-6 weeks
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 2700 patients will be accrued for this study within 475 years
Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab Herceptin in women with operable node-positive breast cancer that overexpresses HER2
Compare the effect of these regimens on disease-free and overall survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive nodes 1-3 vs 4-9 vs 10 or more administration of hormonal therapy tamoxifen vs anastrozole vs neither surgeryradiotherapy lumpectomy plus breast irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy without radiotherapy vs mastectomy with radiotherapy paclitaxel schedule every 3 weeks vs weekly and participating center Patients are randomized to one of two treatment arms
Arm 1 Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses Approximately 3 weeks after the last course patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR paclitaxel IV over 1 hour once weekly for 12 weeks 12 doses
Arm 2 Patients receive chemotherapy as in arm I and trastuzumab Herceptin IV over 90 minutes on day 1 of the first course of paclitaxel Trastuzumab is then administered IV over 30 minutes weekly for 51 weeks beginning on day 8
All patients with estrogen or progesterone receptor-positive tumors receive hormonal therapy for at least 5 years beginning within 3-12 weeks after the last dose of chemotherapy Patients who have received prior tamoxifen for prevention may be treated with additional tamoxifen for no more than 5 years at the discretion of the principal investigator PI
NOTE Other hormonal therapeutic agents are allowed in sequence with or as an alternative to tamoxifen therapy
All patients previously treated with lumpectomy undergo breast irradiation beginning after completion of chemotherapy and concurrently with trastuzumab in arm 2 administration Patients previously treated with mastectomy may also receive radiotherapy Radiotherapy is administered daily for 5-6 weeks
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 2700 patients will be accrued for this study within 475 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 |
|---|---|---|---|
| CDR0000067269 | None | None | None |