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A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases

NCT01305941 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-12-17

Study results available
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Summary

Purpose: This study is a single-arm, open-label phase II clinical trial testing the hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective, safe, and tolerable among patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will come off study.

Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized to the brain.

Conditions

  • HER-2 Positive Breast Cancer

Interventions

DRUG

Everolimus

everolimus 5 mg PO daily as two 2.5-mg tablets

DRUG

Vinorelbine

vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.

DRUG

Trastuzumab

2 mg/kg IV administered over 30 minutes weekly

Sponsors & Collaborators

Principal Investigators

  • Carey K Anders, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-08-31
Completion
2017-10-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01305941 on ClinicalTrials.gov