SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02000882

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase II Multicenter Single-arm Study of BKM120 Plus Capecitabine for Breast Cancer Patients With Brain Metastases

This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).

NCT02000882 Brain Metastases Breast Cancer Metastatic Breast Cancer
MeSH: Breast Neoplasms Neoplasm Metastasis Brain Neoplasms
HPO: Brain neoplasm Breast carcinoma Neoplasm of the breast

3 Interventions

Name: BKM120

Type: Drug

BKM120 plus Capecitabine

Name: capecitabine

Type: Drug

BKM120 plus Capecitabine

Name: Trastuzumab

Type: Drug

BKM120 plus Capecitabine


Primary Outcomes

Description: To determine the clinical benefit rate (CBR) based on local investigator assessment associated with BKM120 once daily plus capecitabine (1000 mg/m2 PO BID 14 days on/7 days off) in patients with metastatic breast cancer with a brain metastasis at least 5mm in size following whole brain radiation therapy (WBRT) and that has not progressed following WBRT. An exploratory analysis will be conducted of patients enrolled on study who have evidence of disease progression following WBRT. Clinical benefit rate is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) in the CNS lasting at least 24 weeks based on local investigator assessment.

Measure: clinical benefit rate (CBR)

Time: until end of study (4 years)

Secondary Outcomes

Description: To assess ORR associated with BKM120 plus capecitabine in the central nervous system based on local investigator assessment

Measure: Objective Response Rate (ORR)

Time: until end of study (4 years)

Description: To assess median time to progression (TTP) associated with BKM120 plus capecitabine.

Measure: Median time to progression

Time: until end of study (4 years)

Description: To determine median overall survival (OS) associated with BKM120 plus capecitabine.

Measure: Median Overall Survival

Time: until end of study (4 years)

Description: To characterize the safety and tolerability of BKM120 plus capecitabine, with or without trastuzumab

Measure: Number of Adverse Events

Time: until end of study (4 years)

Description: To assess median time to deterioration of neurologic function based on answers to questionnaires.

Measure: Median time to deterioration of neurologic function

Time: until end of study (4 years)

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

Patient is able to swallow and retain oral medication 22. Signed most recent patient informed consent form 23. Signed Patient Authorization Form Exclusion Criteria: 1. Patient received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO:
Brain neoplasm
Genes 7
POLD1 POLE RELA APC RB1 FLI1 C11ORF95
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