Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01049425
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2010-01-12
Brief Title:
Anthracycline-free Taxane Based Chemotherapy in Patients With HER2Neu Negative Early Breast Cancer
Sponsor:
West German Study Group
Organization:
West German Study Group
Study Overview
Official Title:
Randomised Comparison of Adjuvant Docetaxel Cyclophosphamide With Sequential Adjuvant EC Docetaxel Chemotherapy in Patients With HER2Neu Negative Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-08
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:
planB
Brief Summary:
The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation anthracyclinetaxane-based regimen in HER2neu non-over expressing tumors The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient who will only have a modest benefit from this compound Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX will be performed to identify patients who should not receive chemotherapy
Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors
Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors
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