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STAR Cape+BKM120 MBC With Brain Met

NCT02000882 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-02-07

Study results available
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Summary

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).

Conditions

Interventions

DRUG

BKM120

DRUG

capecitabine

DRUG

Trastuzumab

Sponsors & Collaborators

Principal Investigators

  • Joyce A. O'Shaughnessy, MD · US Oncology Research, McKesson Specialty Health

  • Morris D. Groves, MD, JD · US Oncology Research, McKesson Specialty Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-29
Primary Completion
2019-03-29
Completion
2019-03-29

Countries

  • United States

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000882 on ClinicalTrials.gov