Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
|ClinicalTrials.gov Identifier: NCT00397761|
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 9, 2006
Last Update Posted : February 9, 2009
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 II/III 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: neoadjuvant therapy||Phase 2 Phase 3|
- Determine the rate of pathological complete response (i.e., 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^®).
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Masking:||None (Open Label)|
|Official Title:||Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer|
|Study Start Date :||July 2006|
U.S. FDA Resources
- Pathological complete response rate
- Overall clinical response rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397761
|United States, District of Columbia|
|Washington Cancer Institute at Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Clinical Trials Office - Washington Cancer Institute 202-877-8839|
|Study Chair:||Anita Aggarwal, DO, PhD||Washington Hospital Center|