Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009997
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2001-02-02
Brief Title:
Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression
Status:
COMPLETED
Status Verified Date:
2011-03
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:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with combination chemotherapy may be an effective treatment for locally advanced breast cancer
PURPOSE Phase I trial to study the effectiveness of trastuzumab plus paclitaxel followed by surgery and combination chemotherapy in treating women who have locally advanced breast cancer
PURPOSE Phase I trial to study the effectiveness of trastuzumab plus paclitaxel followed by surgery and combination chemotherapy in treating women who have locally advanced breast cancer
Detailed Description:
OBJECTIVES I Determine the safety and toxicity of preoperative trastuzumab Herceptin and paclitaxel followed by postoperative doxorubicin and cyclophosphamide in women with locally advanced breast cancer with HER2 overexpression II Determine tumor response in these patients treated with this regimen III Assess the effect of this regimen on tumor histology and the potential molecular determinants of response in these patients
OUTLINE Patients receive trastuzumab Herceptin IV over 30-90 minutes followed by paclitaxel IV over 60 minutes on day 1 Treatment continues every 7 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity Patients undergo a modified radical mastectomy or a lumpectomy with axillary node dissection Beginning 14 days after surgery patients receive doxorubicin IV and cyclophosphamide IV over 15-30 minutes on day 1 Treatment repeats every 21 days for a total of 4 courses After completion of chemotherapy patients with hormone receptor-positive disease receive oral tamoxifen daily for 5 years Patients are followed at 6 months
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
OUTLINE Patients receive trastuzumab Herceptin IV over 30-90 minutes followed by paclitaxel IV over 60 minutes on day 1 Treatment continues every 7 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity Patients undergo a modified radical mastectomy or a lumpectomy with axillary node dissection Beginning 14 days after surgery patients receive doxorubicin IV and cyclophosphamide IV over 15-30 minutes on day 1 Treatment repeats every 21 days for a total of 4 courses After completion of chemotherapy patients with hormone receptor-positive disease receive oral tamoxifen daily for 5 years Patients are followed at 6 months
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1905 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9901 | None | None | None |
| GENENTECH-NYU-9901 | None | None | None |