Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434031
Status:
WITHDRAWN
Last Update Posted:
2012-07-30
First Post:
2007-02-09
Brief Title:
CETRA Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab Caelyx Liposomal Doxorubicin and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CETRA
Brief Summary:
The purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx liposomal doxorubicin cyclophosphamide and trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive breast cancer
Detailed Description:
Chemotherapy in association with trastuzumab a monoclonal antibody given before surgery has been shown to reduce tumor size and permit better resection of HER-2 positive breast cancers This study will evaluate the activity of a neoadjuvant treatment with docetaxel and trastuzumab given every 3 weeks for 4 cycles followed by the combination of caelyx cyclophosphamide and trastuzumab every 3 weeks for 4 cycles Patients will undergo breast cancer surgery 2-5 weeks after the completion of neoadjuvant therapy Adjuvant therapy after surgery will be given according to existing guidelines and will include an additional 10 cycles of trastuzumab
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 |
|---|---|---|---|
| EudraCT number 2006-003993-85 | None | None | None |