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Report for Clinical Trial NCT02000882

Developed by Shray Alag, 2020.
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 Ne 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 8
C11ORF95 POLE APC FLI1 RB1 APC POLD1 RELA
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
Neoplasm of the breast
Genes 123
PPM1D CTNNB1 PTEN MGMT AKT1 BRCA1 SLC22A18 BRCA1 SDHC NTHL1 XRCC3 APC IDH1 LMNA RAD51C CDKN2B PIK3CA PALLD CHEK2 NTHL1 ATM RAD51D ESR1 GNAS APC PIK3CA RASGRP1 SDHD PRKCD KRAS BAP1 IDH2 PALB2 FAS RAD51 RNF43 PRLR AKT1 CHEK2 CDKN2A CDH1 CDK4 RELA BRCA2 BRCA1 TERF2IP CHEK2 MLH1 BRCA1 PRKAR1A POT1 BRCA2 CDH1 TERT APC MLH1 AKT1 TP53 CASP10 TP53 COL14A1 AKT1 OPCML MDM2 POLE BRCA2 PTEN MSH6 RAD51C CASP8 RB1CC1 KRAS ACD PIK3CA BRIP1 MRE11 TP53 STK11 PRKN KLLN MSH2 SEC23B HMMR PTEN POLD1 PIK3CA BRCA1 MITF FAS BRIP1 TP53 BARD1 BARD1 AAGAB SMAD4 RAD50 STK11 RAD54L NBN C11ORF95 SEC23B WRN PTEN NQO2 PTEN PALB2 ATR PALB2 CDKN2A TWIST1 SDHB MSH2 MC1R FASLG RAD51 FGFR2 TP53 PHB PTEN BRCA2 CHEK2 CDKN2A APC