Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309556
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2006-03-31
Brief Title:
Randomized Neoadjuvant Study of Epirubicin and Docetaxel WithWithout Capecitabine in Early Breast Cancer
Sponsor:
Austrian Breast Colorectal Cancer Study Group
Organization:
Austrian Breast Colorectal Cancer Study Group
Study Overview
Official Title:
A Randomized Phase III Study Comparing Epirubicin Docetaxel and Capecitabine G-CSF to Epirubicin and Docetaxel G-CSF as Neoadjuvant Treatment for Early HER-2 Negative Breast Cancer and Comparing Epirubicin Docetaxel and Capecitabine G-CSF Trastuzumab to Epirubicin and Docetaxel G-CSF Trastuzumab as Neoadjuvant Treatment for Early HER-2 Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Primarily this clinical investigation compares the rates percentages of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin docetaxel capecitabine-containing chemotherapy trastuzumab in HER-2 positive disease vs epirubicin docetaxel-containing chemotherapy trastuzumab in HER-2 negative disease
Detailed Description:
This study is a prospective randomized multicentre phase III trial in the neoadjuvant treatment of patients with primary breast cancer and no distant metastases Patients will be stratified at inclusion according to the centre to the clinical tumour stage T1 T2 T3 T4a-c the axillary lymph node status positive negative the menopausal status pre-menopausal post-menopausal histology invasive ductal invasive lobular mixed the hormone-receptor status positive ERPR ERPR- ER-PR negative ER-PR- not determinable the HER-2 status positive negative not determinable the grading G1G2 G3 not determinable and will be randomly assigned to receive either 6 cycles of neoadjuvant epirubicin docetaxel and capecitabine trastuzumab in HER-2 positive disease or 6 cycles of neoadjuvant epirubicin and docetaxel trastuzumab in HER-2 positive disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Ro 09-1978 | OTHER | Roche Study ID | None |