Ignite Creation Date:
2024-05-05 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00550771
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2007-10-29
Brief Title:
Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer Study P05048
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy in Patients With HER2-positive Breast Cancer Caelyx Cyclophosphamide Trastuzumab CCH or Doxorubicin Cyclophosphamide AC Each Followed by Paclitaxel Trastuzumab TH BACH
Status:
COMPLETED
Status Verified Date:
2017-05
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 compare the incidence of cardiac dysfunction in subjects with human epidermal growth factor receptor 2 HER2 positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin PLD both in combination with trastuzumab
Detailed Description:
None
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