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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 Neoplasm Metastasis Brain Neoplasms
HPO:Brain neoplasm Breast carcinoma Neoplasm of the breast

3 Interventions

Name: BKM120

Type: Drug
Group Labels: 1

BKM120 plus Capecitabine

Name: capecitabine

Type: Drug
Group Labels: 1

BKM120 plus Capecitabine

Name: Trastuzumab

Type: Drug
Group Labels: 1

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

Allocation: N/A

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: