SNPMiner Trials by Shray Alag


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Report for SNP rs7349683

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 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 Drug: Eribulin Mesylate Other: Laboratory Biomarker Analysis Drug: Paclitaxel Other: Quality-of-Life Assessment
MeSH: Breast Neoplasms Adenocarcinoma
HPO: Breast carcinoma Neoplasm of the breast

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).

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 initiation

Description: 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 years

Secondary 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 years

Description: 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 years

Description: 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 years

Description: 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 to

Description: 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 4.0

Description: 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 years

Description: 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 years

Description: 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 weeks

Description: 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 weeks

Other Outcomes

Description: Will be summarized using the Kaplan-Meier method according to treatment group.

Measure: New metastasis free survival

Time: Up to 5 years


HPO Nodes


Breast carcinoma
Genes 95
TP53 PPM1D CTNNB1 TP53 COL14A1 AKT1 AKT1 OPCML MDM2 BRCA1 SLC22A18 POLE BRCA2 BRCA1 SDHC NTHL1 PTEN XRCC3 MSH6 IDH1 RAD51C RAD51C CASP8 RB1CC1 PIK3CA PALLD KRAS PIK3CA CHEK2 BRIP1 MRE11 NTHL1 ATM TP53 RAD51D STK11 PRKN ESR1 PIK3CA KLLN MSH2 SDHD KRAS SEC23B HMMR PTEN POLD1 PIK3CA IDH2 BRCA1 PALB2 BRIP1 TP53 RAD51 RNF43 BARD1 BARD1 AAGAB AKT1 SMAD4 RAD50 STK11 CHEK2 RAD54L NBN CDKN2A SEC23B CDH1 WRN NQO2 PALB2 ATR PALB2 TWIST1 SDHB MSH2 BRCA2 BRCA1 RAD51 CHEK2 MLH1 BRCA1 FGFR2 TP53 PHB BRCA2 CDH1 PTEN BRCA2 CHEK2 CDKN2A APC MLH1 AKT1 APC