Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331630
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2006-05-30
Brief Title:
Abraxane and Lapatinib in Treating Patients With Stage I Stage II or Stage III Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 Abraxane and GW572016 Lapatinib
Status:
COMPLETED
Status Verified Date:
2020-01
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 Drugs used in chemotherapy such as Abraxane work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth Giving Abraxane together with lapatinib may kill more tumor cells
PURPOSE This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I stage II or stage III breast cancer
PURPOSE This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate as measured by clinical exam and imaging studies in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combination with lapatinib
Secondary
Determine the pathologic complete response rate in patients treated with this regimen
Correlate proliferation Ki67 apoptosis cleaved caspase-3 and angiogenesis vW CD34 markers measured before and after treatment with tumor response in these patients
Conduct other correlative studies including epidermal growth factor receptor EGFR HER2neu matrix metalloproteinases MMPs and transforming growth factor TGF-β before and after treatment with this regimen to assess tumor response in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a pilot study Patients are assigned to 1 of 2 treatment groups
Group 1 The first 10 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Group 2 The next 20 patients receive Abraxane and lapatinib at a higher dose as in group 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection and tumor biopsies periodically for correlative biomarker studies
PROJECTED ACCRUAL A total of 30 patients will be accrued to this study
Primary
Determine the clinical response rate as measured by clinical exam and imaging studies in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combination with lapatinib
Secondary
Determine the pathologic complete response rate in patients treated with this regimen
Correlate proliferation Ki67 apoptosis cleaved caspase-3 and angiogenesis vW CD34 markers measured before and after treatment with tumor response in these patients
Conduct other correlative studies including epidermal growth factor receptor EGFR HER2neu matrix metalloproteinases MMPs and transforming growth factor TGF-β before and after treatment with this regimen to assess tumor response in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a pilot study Patients are assigned to 1 of 2 treatment groups
Group 1 The first 10 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Group 2 The next 20 patients receive Abraxane and lapatinib at a higher dose as in group 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection and tumor biopsies periodically for correlative biomarker studies
PROJECTED ACCRUAL A total of 30 patients will be accrued to 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 |
|---|---|---|---|
| STU00007257 | OTHER | Northwestern University IRB | None |
| NU 05B2 | OTHER | None | None |