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Report for Clinical Trial NCT02037529
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Drugs used in chemotherapy, such as eribulin mesylate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT02037529 Breast Adenocarcinoma HER2/Neu Negative Invasive Breast Carcinoma Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 MeSH: Breast Neoplasms Adenocarcinoma
HPO: Breast carcinoma Neoplasm of the breast
4 Interventions
Name: Eribulin Mesylate
Description: Given IVType: DrugArm A (eribulin mesylate)
Name: Laboratory Biomarker Analysis
Description: Correlative studiesType: OtherArm A (eribulin mesylate) Arm B (paclitaxel)
Name: Paclitaxel
Description: Given IVType: DrugArm B (paclitaxel)
Name: Quality-of-Life Assessment
Description: Ancillary studiesType: OtherArm A (eribulin mesylate) Arm B Arm B (paclitaxel)
Primary Outcomes
Description: The patient-reported maximum score (post baseline) across Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items for each patient will be computed over the first 12 weeks and compared between arms using a two-sample independent samples t-test.
Measure: Patient-reported maximum score Time: Up to 12 weeks after treatment initiationDescription: The Cox score test will be used to test the association between the cumulative dose level triggering toxicity and the genotype. The goal is to validate the EPHA5 rs7349683 single neucleotide polymorphism (SNP).
Measure: Validation of germline EPHA5 polymorphism (rs7349683) Time: Up to 5 yearsSecondary Outcomes
Description: The primary analysis will use the stratified log-rank tests, as described for overall survival. As a secondary analysis we will use a multivariable Cox proportional hazard model to estimate adjusted hazard ratios for eribulin mesylate over standard weekly paclitaxel, study stratification factors, and covariates for known prognostic factors, including disease free interval and visceral versus non-visceral metastases. Survival functions will be summarized using the Kaplan-Meier method according to treatment group.
Measure: Overall survival (OS) Time: From randomization to death due to any cause, assessed up to 5 yearsDescription: The primary analysis will use the Cochran-Mantel-Haenszel chi-squared test with study stratification factors. Secondary analyses will use logistic regression to test differences in proportions while controlling for the covariates. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.
Measure: Objective tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Time: Up to 5 yearsDescription: Will be summarized using the Kaplan-Meier method. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.
Measure: Duration of response Time: Up to 5 yearsDescription: Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.
Measure: Time to treatment failure Time: Up toDescription: The primary analysis will use the Cochran-Mantel-Haenszel chi-squared test with study stratification factors. Secondary analyses will use logistic regression to test differences in proportions while controlling for the covariates. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.
Measure: Incidence of treatment related adverse events Time: Up to 30 days after last dose assessed by CTCAE version 4.0Description: Will be summarized using the Kaplan-Meier method. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.
Measure: Time to new metastasis Time: Up to 5 yearsDescription: Will be summarized using the Kaplan-Meier method. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.
Measure: Progression free survival assessed by RECIST 1.1 criteria Time: From randomization to progression or death due to any cause, whichever occurs first, assessed up to 5 yearsDescription: Additional analyses will include the previously described analysis conducted over the first 24 weeks; a comparison of the incidence of patient-reported maximum score >= 3 between arms through 12 and 24 weeks using chi-squared testing for each item; and a comparison of the time to patient-reported score >= 3 between arms using Kaplan-Meier and log-rank analyses. Further, these three endpoints will be compared between patient- and clinician-report overall and within arms using appropriate paired analyses.
Measure: Patient reported neurotoxicity Time: Up to 24 weeksDescription: The PRO-CTCAE sensory neuropathy items will be further validated by computing Pearson correlations between each item and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20 )sensory scale score at baseline, 12 and 24 weeks.
Measure: Validation of PRO-CTCAE sensory neuropathy item Time: At baseline, 12 and 24 weeksOther Outcomes
Description: Will be summarized using the Kaplan-Meier method according to treatment group.
Measure: New metastasis free survival Time: Up to 5 yearsPurpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs7349683
The patient-reported maximum score (post baseline) across Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items for each patient will be computed over the first 12 weeks and compared between arms using a two-sample independent samples t-test.. Validation of germline EPHA5 polymorphism (rs7349683).
The goal is to validate the EPHA5 rs7349683 single neucleotide polymorphism (SNP).. Overall survival (OS).
To validate rs7349683 in EPHA5 as a predictor of peripheral neuropathy from treatment with a microtubule targeting agent (i.e., eribulin or paclitaxel).