Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464646
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2007-04-19
Brief Title:
Therapy With Bevacizumab BEV Epirubicin and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function This study will evaluate
How bevacizumab given with chemotherapy and then bevacizumab given with trastuzumab after surgery will affect breast tumors
Side effects from adding bevacizumab to chemotherapy and trastuzumab
Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart
If receiving bevacizumab will have any effect on how patients recover from surgery
How bevacizumab given with chemotherapy and then bevacizumab given with trastuzumab after surgery will affect breast tumors
Side effects from adding bevacizumab to chemotherapy and trastuzumab
Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart
If receiving bevacizumab will have any effect on how patients recover from surgery
Detailed Description:
NSABP FB-5 is a Phase II study for women with HER2-positive invasive breast cancer evaluating a regimen of epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab and bevacizumab in two patient cohorts
Cohort A Women with unresected locally advanced breast cancer clinical Stage IIIA IIIB and IIIC
Cohort B Women with resected pN2 or pN3 pathologic Stage III breast cancer
The primary aims of the study are to determine the rate of cardiac events for all patients and the pCR rate in the breast and axillary lymph nodes for Cohort A Cardiac events will be defined as NYHA Class IIIIV congestive heart failure and cardiac death For Cohort A secondary aims of the study include determining the rate of pCR in the breast and the cCR rate following the neoadjuvant therapy The secondary aims also include determining the value of the regimen in improving 5-year RFS and 5-year OS and determining the non-cardiac toxicities of the regimen in all patients
Patients in Cohort A will receive neoadjuvant therapy consisting of epirubicin plus cyclophosphamide EC every 21 days for 4 cycles plus bevacizumab given on Day 1 of Cycle 4 only followed by docetaxel every 21 days for 4 cycles plus bevacizumab every 21 days for the initial 3 cycles Patients will also receive weekly trastuzumab beginning with the first cycle of docetaxel and continuing until 1-7 days before surgery Patients will then have breast surgery lumpectomy or mastectomy with axillary staging Approximately 4-6 weeks following surgery bevacizumab and trastuzumab will resume and continue every 3 weeks for 13 doses to complete one year of targeted therapy
Patients in Cohort B will receive adjuvant therapy consisting of EC every 21 days for 4 cycles followed by docetaxel every 21 days for 4 cycles Beginning with the first cycle of docetaxel patients will also receive bevacizumab every 21 days for 4 cycles and weekly trastuzumab until 3 weeks after the last docetaxel dose Beginning 3 weeks after the last dose of docetaxel both bevacizumab and trastuzumab will then be given every 3 weeks for 13 doses to complete 1 year of targeted therapy
Cardiac monitoring will be conducted for both cohorts For Cohort A LVEF assessments will be conducted at baseline post-EC 2-4 weeks following surgery about 6 months from study entry and 9 12 15 and 18 months from study entry For Cohort B LVEF assessments will be conducted at baseline post-EC and 6 9 12 15 and 18 months from study entry The preferred method for LVEF assessment is 2-D echocardiogram however LVEF assessment by MUGA scan is permitted
Patient follow-up will continue for 5 years following study entry
The FB-5 sample size is 105 patients
Cohort A Women with unresected locally advanced breast cancer clinical Stage IIIA IIIB and IIIC
Cohort B Women with resected pN2 or pN3 pathologic Stage III breast cancer
The primary aims of the study are to determine the rate of cardiac events for all patients and the pCR rate in the breast and axillary lymph nodes for Cohort A Cardiac events will be defined as NYHA Class IIIIV congestive heart failure and cardiac death For Cohort A secondary aims of the study include determining the rate of pCR in the breast and the cCR rate following the neoadjuvant therapy The secondary aims also include determining the value of the regimen in improving 5-year RFS and 5-year OS and determining the non-cardiac toxicities of the regimen in all patients
Patients in Cohort A will receive neoadjuvant therapy consisting of epirubicin plus cyclophosphamide EC every 21 days for 4 cycles plus bevacizumab given on Day 1 of Cycle 4 only followed by docetaxel every 21 days for 4 cycles plus bevacizumab every 21 days for the initial 3 cycles Patients will also receive weekly trastuzumab beginning with the first cycle of docetaxel and continuing until 1-7 days before surgery Patients will then have breast surgery lumpectomy or mastectomy with axillary staging Approximately 4-6 weeks following surgery bevacizumab and trastuzumab will resume and continue every 3 weeks for 13 doses to complete one year of targeted therapy
Patients in Cohort B will receive adjuvant therapy consisting of EC every 21 days for 4 cycles followed by docetaxel every 21 days for 4 cycles Beginning with the first cycle of docetaxel patients will also receive bevacizumab every 21 days for 4 cycles and weekly trastuzumab until 3 weeks after the last docetaxel dose Beginning 3 weeks after the last dose of docetaxel both bevacizumab and trastuzumab will then be given every 3 weeks for 13 doses to complete 1 year of targeted therapy
Cardiac monitoring will be conducted for both cohorts For Cohort A LVEF assessments will be conducted at baseline post-EC 2-4 weeks following surgery about 6 months from study entry and 9 12 15 and 18 months from study entry For Cohort B LVEF assessments will be conducted at baseline post-EC and 6 9 12 15 and 18 months from study entry The preferred method for LVEF assessment is 2-D echocardiogram however LVEF assessment by MUGA scan is permitted
Patient follow-up will continue for 5 years following study entry
The FB-5 sample size is 105 patients
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