Randomized Study of Ixabepilone Versus Observation in Patients With Significant Residual Disease
|ClinicalTrials.gov Identifier: NCT00877500|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Ixabepilone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Study of Ixabepilone vs. Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2/Neu-negative Breast Cancer|
|Actual Study Start Date :||April 2009|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Group 1 Ixabepilone
Ixabepilone 40 mg/m^2 by vein over 3 hours on Day 1 of each 21-day study cycle for up to 6 cycles.
40 mg/m^2 by vein over 3 hours on Day 1 of each 21-day study cycle for up to 6 cycles.
No Intervention: Group 2 Observation
Standard of care treatments for disease.
- Genomic (transcriptional profiles) + Proteomic (pathway activation) Tumor Features [ Time Frame: Blood tests Day 1 of each 21-day cycle (up to 6 cycles) ]Signaling pathway analysis through reverse phase protein arrays (RPPA) used to objectively quantify (phospho) protein expression. Functional activation of the pathway defined as an increase in phosphorylation of at least one half of the components of each pathway above the median RPPA quantified activation across the entire tumor set.
- Number of Circulating Tumor Cells (CTCs) [ Time Frame: At 18 weeks (+/- 7 days) of therapy following surgery ]Number of Circulating Tumor Cells defined as the presence of any cell per 7.5 ml of whole blood.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877500
|United States, Illinois|
|Advocate Christ Medical Center|
|Oak Lawn, Illinois, United States, 60453|
|United States, Texas|
|Lyndon B. Johnson General Hospital|
|Houston, Texas, United States, 77026|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Funda Meric-Bernstam, MD||M.D. Anderson Cancer Center|