Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148668
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
2005-09-07
Brief Title:
Preoperative HerceptinNavelbine Versus TaxotereCarboplatinHerceptin in HER-2 Positive Breast Cancer
Sponsor:
Eric Winer MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Phase II Study of Preoperative HerceptinNavelbine Versus TaxotereCarboplatinHerceptin in Early Stage HER-2 Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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 study is to find out what effects the preoperative combination therapies of herceptinnavelbine or herceptintaxoterecarboplatin will have on patients with early stage HER-2 positive breast cancer
Detailed Description:
Before starting treatment a clip will be placed via catheter into the tumor bed so the surgeon can locate the site of the tumor During clip placement tissue biopsy will be taken of the tumor One to two weeks after the first dose of herceptin another biopsy will be performed
Patients will be placed into one of 2 arms
Arm 1 receives 12 weeks of herceptin and navelbine Arm 2 receives 4 cycles of taxoterecarboplatinherceptin
Arm 2 participants will also receive neulasta growth factor support on day 2 of each cycle
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly taxotere and carboplatin every 3 weeks Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin taxotere and carboplatin
Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery
Patients will be placed into one of 2 arms
Arm 1 receives 12 weeks of herceptin and navelbine Arm 2 receives 4 cycles of taxoterecarboplatinherceptin
Arm 2 participants will also receive neulasta growth factor support on day 2 of each cycle
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly taxotere and carboplatin every 3 weeks Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin taxotere and carboplatin
Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery
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