Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096343
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2004-11-09
Brief Title:
Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed Locally Advanced Breast Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-11
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 paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy before surgery may shrink the tumor so that it can be removed Combining paclitaxel with carboplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed locally advanced breast cancer
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed locally advanced breast cancer
Detailed Description:
OBJECTIVES
Determine the clinical and pathological response in women with newly diagnosed locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin
Evaluate specific biomarkers for prognostic value and as markers for responseresistance in patients treated with this regimen
Determine the tolerability and toxicity of this regimen in these patients
OUTLINE This is an open-label study
Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo lumpectomy or modified radical mastectomy Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy
Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 18 months
Determine the clinical and pathological response in women with newly diagnosed locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin
Evaluate specific biomarkers for prognostic value and as markers for responseresistance in patients treated with this regimen
Determine the tolerability and toxicity of this regimen in these patients
OUTLINE This is an open-label study
Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo lumpectomy or modified radical mastectomy Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy
Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| UAB-0137 | None | None | None |