Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045032
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2002-09-06
Brief Title:
Herceptin Trastuzumab in Treating Women With Human Epidermal Growth Factor Receptor HER 2-Positive Primary Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Three-Arm Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-03
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:
HERA
Brief Summary:
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years versus observationno Herceptin in women with HER2-overexpressing primary breast cancer who have completed neo-adjuvant systemic chemotherapy definitive surgery and radiotherapy if applicable Efficacy and safety will be assessed for 10 years from randomization for each participant All participants will continue to be followed for survival until 10 years after enrollment of the last participant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IBCSG-28-02 | None | None | None |
| BIG-01-01 | None | None | None |
| EU-20216 | None | None | None |
| ROCHE-B016348E | None | None | None |
| ROCHE-B016348C | None | None | None |
| EORTC-10011 | None | None | None |
| CAN-NCIC-MA24 | None | None | None |