Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00723125
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2008-07-15
Brief Title:
Carboplatin Abraxane Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer
Sponsor:
William Sikov MD
Organization:
Brown University
Study Overview
Official Title:
Q3week Carboplatin With Weekly Abraxaneä And Avastin Subsequent Dose-Dense Ac With Avastin As Neoadjuvant Therapy In Resectable And Unresectable Stage Iia-Iiib Her2-Negative 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:
In the MDACCBrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide FAC the pathologic complete response pCR rate in HER2- patients was 20 The investigators goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30 in patients with HER2- disease Based on a 1-sided 95 confidence interval using normal approximation with an expected pCR rate of at least 35 approximately 28 patients are required for each cohort With an assumed pCR rate of at least 35 the investigators will have approximately 70 statistical power to conclude with 90 certainty that the pCR rate with the novel regimen exceeds 20 The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10
Detailed Description:
See above brief summary
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