Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397761
Status:
WITHDRAWN
Last Update Posted:
2021-02-17
First Post:
2006-11-08
Brief Title:
Capecitabine and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Combination Capecitabine Xeloda and ABI-007 Abraxane Nanoparticle Albumin-Bound Paclitaxel Chemotherapy as Neoadjuvant Treatment of Locally Advanced Operable Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2021-02
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 capecitabine and paclitaxel albumin-stablized nanoparticle formulation work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase IIIII trial is studying how well giving capecitabine together with paclitaxel albumin-stabilized nanoparticle formulation works in treating women undergoing surgery for stage II or stage III breast cancer
PURPOSE This phase IIIII trial is studying how well giving capecitabine together with paclitaxel albumin-stabilized nanoparticle formulation works in treating women undergoing surgery for stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the rate of pathological complete response ie tumor completely gone in women with previously untreated unresected stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel albumin-stabilized nanoparticle formulation Abraxane
Secondary
Evaluate the safety of this regimen in these patients
Determine overall clinical response rate in patients treated with this regimen
OUTLINE Patients receive up to 4 courses of capecitabine and paclitaxel nanoparticle albumin-stabilized formulation Abraxane in the absence of disease progression Patients then undergo definitive surgical resection of the tumor off study
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Primary
Determine the rate of pathological complete response ie tumor completely gone in women with previously untreated unresected stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel albumin-stabilized nanoparticle formulation Abraxane
Secondary
Evaluate the safety of this regimen in these patients
Determine overall clinical response rate in patients treated with this regimen
OUTLINE Patients receive up to 4 courses of capecitabine and paclitaxel nanoparticle albumin-stabilized formulation Abraxane in the absence of disease progression Patients then undergo definitive surgical resection of the tumor off study
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WHC-MRI-GU-2006-097 | None | None | None |