Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006110
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2000-08-03
Brief Title:
Multimodality Treatment for Women With Stage II Stage III or Stage IV Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Nonrandomized Ph II Study of Multimodality Therapy for Stg IIB IIIAB or Stg IV Breast Cancer w4 Cycles of Adriamycin and Cytoxan ACFollowed by 12 Weeks of Paclitaxel w or wo Herceptin Followed by Local Therapy Followed by Wkly Herceptin or no Additional Therapy
Status:
COMPLETED
Status Verified Date:
2017-06
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:
NRR
Brief Summary:
RATIONALE Drugs used in chemotherapy 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 Combining chemotherapy monoclonal antibody therapy and surgery may be a more effective treatment for breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy monoclonal antibody therapy and surgery in treating women who have stage II stage III or stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy monoclonal antibody therapy and surgery in treating women who have stage II stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the cardiac and other toxicity of paclitaxel when administered with trastuzumab Herceptin after doxorubicin and cyclophosphamide in women with stage IIB IIIA IIIB IIIC or previously untreated stage IV breast cancer
Determine whether the addition of paclitaxel with or without trastuzumab to conventional breast cancer adjuvant therapy doxorubicin and cyclophosphamide further decreases tumor size and the number of positive axillary nodes in these patients
Determine the 5-year disease-free survival and overall survival of patients treated with these regimens
Determine whether the initial pathologic response in patients receiving neoadjuvant therapy correlates with the eventual 5-year disease-free survival or overall survival
Compare the number of patients eligible for breast-conserving cancer surgery after treatment with doxorubicin and cyclophosphamide vs paclitaxel and trastuzumab
Correlate clinical and radiographic response rate with pathologic response rate in the primary tumor and axillary lymph nodes and determine which parameter best determines the pathologic response rate in patients treated with these regimens
OUTLINE Patients either received neoadjuvant therapy HER-2 overexpressing and non-overexpressing patients or adjuvant therapy HER-2 overexpressing patients only
Neoadjuvant therapy Patients receive one of two treatment regimens
Regimen I HER-2 non-overexpressing patients or HER-2 overexpressing patients who refuse trastuzumab Herceptin therapy Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes and paclitaxel IV over 3 hours on day 1 every 3 weeks for a total of 4 courses Patients then undergo surgery with or without adjuvant radiotherapy andor oral tamoxifen
Regimen II HER-2 overexpressing patients only Patients receive doxorubicin and cyclophosphamide as in regimen I After completion of course 4 patients receive paclitaxel IV and trastuzumab IV over 90-150 minutes weekly on weeks 13-24 Patients then undergo surgery with or without adjuvant radiotherapy Patients then receive trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if they did receive radiotherapy
Adjuvant therapy Patients who receive adjuvant therapy HER-2 overexpressing patients only receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 every 3 weeks for a total of 4 courses After completion of course 4 patients receive paclitaxel IV and trastuzumab IV over 90 minutes weekly on weeks 13-24 Patients then may undergo radiotherapy followed by trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if they did receive radiotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 125 patients 100 in the neoadjuvant group and 25 in the adjuvant group will be accrued for this study within 5 years
Determine the cardiac and other toxicity of paclitaxel when administered with trastuzumab Herceptin after doxorubicin and cyclophosphamide in women with stage IIB IIIA IIIB IIIC or previously untreated stage IV breast cancer
Determine whether the addition of paclitaxel with or without trastuzumab to conventional breast cancer adjuvant therapy doxorubicin and cyclophosphamide further decreases tumor size and the number of positive axillary nodes in these patients
Determine the 5-year disease-free survival and overall survival of patients treated with these regimens
Determine whether the initial pathologic response in patients receiving neoadjuvant therapy correlates with the eventual 5-year disease-free survival or overall survival
Compare the number of patients eligible for breast-conserving cancer surgery after treatment with doxorubicin and cyclophosphamide vs paclitaxel and trastuzumab
Correlate clinical and radiographic response rate with pathologic response rate in the primary tumor and axillary lymph nodes and determine which parameter best determines the pathologic response rate in patients treated with these regimens
OUTLINE Patients either received neoadjuvant therapy HER-2 overexpressing and non-overexpressing patients or adjuvant therapy HER-2 overexpressing patients only
Neoadjuvant therapy Patients receive one of two treatment regimens
Regimen I HER-2 non-overexpressing patients or HER-2 overexpressing patients who refuse trastuzumab Herceptin therapy Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes and paclitaxel IV over 3 hours on day 1 every 3 weeks for a total of 4 courses Patients then undergo surgery with or without adjuvant radiotherapy andor oral tamoxifen
Regimen II HER-2 overexpressing patients only Patients receive doxorubicin and cyclophosphamide as in regimen I After completion of course 4 patients receive paclitaxel IV and trastuzumab IV over 90-150 minutes weekly on weeks 13-24 Patients then undergo surgery with or without adjuvant radiotherapy Patients then receive trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if they did receive radiotherapy
Adjuvant therapy Patients who receive adjuvant therapy HER-2 overexpressing patients only receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 every 3 weeks for a total of 4 courses After completion of course 4 patients receive paclitaxel IV and trastuzumab IV over 90 minutes weekly on weeks 13-24 Patients then may undergo radiotherapy followed by trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if they did receive radiotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 125 patients 100 in the neoadjuvant group and 25 in the adjuvant group 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 |
|---|---|---|---|
| NCI-G00-1836 | OTHER_GRANT | NCI | None |
| LCCC9818 | OTHER | None | None |