Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy
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|ClinicalTrials.gov Identifier: NCT00877500|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Breast Carcinoma HER2/Neu Negative Invasive Breast Carcinoma||Other: Best Practice Drug: Ixabepilone||Phase 2|
I. To investigate the genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors that do not achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) and correlate these features with outcome in the presence and absence of adjuvant ixabepilone.
II. To evaluate the presence of circulating tumor cells (CTCs) at baseline (before chemotherapy starts; if radiation is used, after radiation ends), during and after ixabepilone therapy or during observation.
I. To collect serial blood samples for future pharmacogenomic studies. II. To determine if the addition of adjuvant ixabepilone will improve recurrence-free survival in patients that have significant residual HER 2/neu-negative breast cancer after NST.
III. To assess the toxicity of adjuvant ixabepilone in this group of patients.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (IXABEPILONE): Participants receive ixabepilone intravenously (IV) over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
GROUP II (STANDARD OF CARE): Participants receive standard of care for 18 weeks.
After completion of study treatment, participants are followed up every 3 months for 2 years and every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel 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 :||March 30, 2009|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: Group I (ixabepilone)
Participants receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Active Comparator: Group II (standard of care)
Participants receive standard of care for 18 weeks.
Other: Best Practice
Receive standard of care
- Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors [ Time Frame: Up to 5 years ]RPPA will be used to objectively quantify (phospho)protein expression. Functional activation of the pathway will be 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. Data will be analyzed for the presence of clusters based on differential protein expression by using available methods with the R statistical software package. A variety of unsupervised clustering methods (including hierarchical clustering, K-means, independent component analysis, mutual information, and gene shaving) will be used to classify the samples into statistically similar groups.
- Significant circulating tumor cells (CTCs) [ Time Frame: At 18 weeks ]Presence of any cell per 7.5 ml of whole blood.
- Incidence of adverse events in each group [ Time Frame: Up to 5 years ]Chi-square tests of independence and generalized logistic regression models will be used.
- Recurrence-free survival [ Time Frame: Up to 5 years ]Will be estimated non-parametrically using the Kaplan-Meier product limit method. Cox proportional hazards regression models will be used to model recurrence-free survival as a function of treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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, 60453-2699|
|United States, Texas|
|Lyndon Baines Johnson General Hospital|
|Houston, Texas, United States, 77026-1967|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Funda Meric-Bernstam||M.D. Anderson Cancer Center|