Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308178
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2006-03-28
Brief Title:
Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer
Sponsor:
Harold J Burstein MD PhD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Dose Dense AB1-007 Abraxane in Adjuvant Chemotherapy for Breast Cancer A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2013-02
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:
The purpose of this trial is to see if Abraxane which is a new form of paclitaxel is safe as a replacement form of paclitaxel in dose-dense chemotherapy This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF a white blood cell stimulating growth factor
Detailed Description:
Patients will receive regular chemotherapy every 2 weeks for up to 8 cycles approximately 16 weeks totalof treatment During the first four cycles patients will be treated with Adriamycin and Cytoxan and for the second four cycles they will be treated with Abraxane
Patients will be taught to give themselves injections with either short or long acting G-CSF as prescribed by their doctor for the first four cycles of chemotherapy During the last four cycles while the patient is taking Abraxane they will not receive G-CSF unless they have low blood counts
If the patient has HER-2 positive breast cancer they will also receive 52 weeks of Herceptin as part of standard cancer care and will begin to receive Herceptin at the same time they begin Abraxane after 4 cycles of adriamycin and cytoxan treatment
This study involves a series of Quality of Life Questionnaires that will be completed prior to beginning study treatment then again at 2 months 4 months 6 months and 1 year after starting study treatment
The following tests and procedures will be performed at the time periods specified Cycle 1-4 Day 1 Physical exam vital signs and blood tests Cycle 5 Day 1 Physical exam vital signs blood tests RVG measurement of heart function and questionnaire Cycle 6 7 Day 1 Physical exam vital signs and blood tests Cycle 8 Day 1 physical exam vital signs blood tests questionnaire Follow-up 6 months and 1 year after cycle 1 day 1 questionnaire
Patients will be taught to give themselves injections with either short or long acting G-CSF as prescribed by their doctor for the first four cycles of chemotherapy During the last four cycles while the patient is taking Abraxane they will not receive G-CSF unless they have low blood counts
If the patient has HER-2 positive breast cancer they will also receive 52 weeks of Herceptin as part of standard cancer care and will begin to receive Herceptin at the same time they begin Abraxane after 4 cycles of adriamycin and cytoxan treatment
This study involves a series of Quality of Life Questionnaires that will be completed prior to beginning study treatment then again at 2 months 4 months 6 months and 1 year after starting study treatment
The following tests and procedures will be performed at the time periods specified Cycle 1-4 Day 1 Physical exam vital signs and blood tests Cycle 5 Day 1 Physical exam vital signs blood tests RVG measurement of heart function and questionnaire Cycle 6 7 Day 1 Physical exam vital signs and blood tests Cycle 8 Day 1 physical exam vital signs blood tests questionnaire Follow-up 6 months and 1 year after cycle 1 day 1 questionnaire
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