Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00546156
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2007-10-17
Brief Title:
Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer
Sponsor:
Ian E Krop MD PhD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Preoperative Dose-dense dd Doxorubicin and Cyclophosphamide AC Followed by Paclitaxel T With Bevacizumab in ER andor PR HER2-negative Operable Breast Cancer
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:
Dose dense chemotherapy which is the term for Adriamycin and Cyclophosphamide AC followed by Taxol chemotherapy given every two weeks is the standard chemotherapy for the treatment of ER or PR breast cancer In this trial the standard chemotherapy is being combined with bevacizumab Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF vascular endothelial growth factor Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer However it is not approved for the treatment of breast cancer Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment
Detailed Description:
To prepare for the surgery that will occur at the end of the study treatment a small clip will be placed into the tumor area so that the surgeon can locate the site of the tumor at the time of surgery This is a standard procedure for breast cancer
During the clip placement a needle will be inserted into the tumor to measure interstitial fluid pressure IFP measurement IFP is done for research purposes to help understand how the tumor responds to the study treatment
Study treatment will begin with one dose of bevacizumab alone followed two weeks later by chemotherapy and bevacizumab in eight two-week cycles The study treatment will be given intravenously in the clinic
After the first dose of bevacizumab and prior to starting chemotherapy a needle biopsy of the breast tumor will be performed for research purposes A second measurement of IFP will also be done at this time
During the treatment period tests and procedures will be performed at specified intervals and include the following research MRI physical exams blood tests urine tests EKG and MUGA or ECHO
Surgery to remove the tumor will occur no less than four weeks after the last dose of Paclitaxel
During the clip placement a needle will be inserted into the tumor to measure interstitial fluid pressure IFP measurement IFP is done for research purposes to help understand how the tumor responds to the study treatment
Study treatment will begin with one dose of bevacizumab alone followed two weeks later by chemotherapy and bevacizumab in eight two-week cycles The study treatment will be given intravenously in the clinic
After the first dose of bevacizumab and prior to starting chemotherapy a needle biopsy of the breast tumor will be performed for research purposes A second measurement of IFP will also be done at this time
During the treatment period tests and procedures will be performed at specified intervals and include the following research MRI physical exams blood tests urine tests EKG and MUGA or ECHO
Surgery to remove the tumor will occur no less than four weeks after the last dose of Paclitaxel
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