SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00079326

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 2 Study of Trastuzumab in Combination With BMS-247550 in Women With Metastatic Breast Cancer

This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.

NCT00079326 HER2-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
MeSH: Breast Neoplasms
HPO: Breast carcinoma Neoplasm of the breast

3 Interventions

Name: trastuzumab

Description: Given IV

Type: Biological

Treatment (trastuzumab, ixabepilone)

Name: ixabepilone

Description: Given IV

Type: Drug

Treatment (trastuzumab, ixabepilone)

Name: laboratory biomarker analysis

Description: Correlative studies

Type: Other

Treatment (trastuzumab, ixabepilone)


Primary Outcomes

Description: Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.

Measure: Overall Response Rate

Time: Up to 6 years

Secondary Outcomes

Description: Time to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.

Measure: Time to Treatment Failure (TTF)

Time: up to 6 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

HER2/phospho-HER2, EGFR/phospho-EGFR, IGRF-I, phospho-MAPK, phospho-P13K, bcl-2, bcl-xL, MDR-1, MRP and β-tubulin) and blood biomarkers (HER2-extracellular domain [ECD], circulating tumor cells) to correlate them with response to treatment. --- P13K ---



HPO Nodes


HPO:
Breast carcinoma
Genes 51
RAD51 RAD51C RAD51D CDKN2A KRAS MRE11 SLC22A18 STK11 MSH6 KLLN BRIP1 BRCA1 ATR BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 WRN CHEK2 APC BARD1 MLH1 NBN COL14A1 AKT1 PRKN MSH2 FGFR2 IDH1 IDH2 CTNNB1 RB1CC1 PTEN MDM2 AAGAB CDH1 RNF43 PALLD PALB2 OPCML SEC23B TP53 SDHB SDHC SDHD SMAD4 TWIST1 RAD50
Neoplasm of the breast
Genes 73
RAD51 RAD51C RAD51D CDKN2A KRAS CDKN2B CDKN2D MRE11 SLC22A18 STK11 MSH6 RASGRP1 KLLN BRIP1 MGMT BRCA1 LMNA ATR ACD BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 POT1 MC1R MITF WRN CHEK2 APC BARD1 MLH1 PRKAR1A CASP10 NBN PRKCD COL14A1 AKT1 C11ORF95 PRKN RELA MSH2 FGFR2 IDH1 GNAS IDH2 CTNNB1 RB1CC1 PTEN MDM2 FAS FASLG AAGAB CDH1 TERT RNF43 PALLD PALB2 OPCML TERF2IP PRLR SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 TWIST1 RAD50