Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer

NACompletedINTERVENTIONAL
Enrollment

283

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Breast Cancer
Interventions
PROCEDURE

PRO Onc Assay and Treatment

Patients with HER2-negative metastatic breast cancer will be identified, and blood specimens will be obtained from each participant. The PRO Onc Assay will be performed on CTCs isolated from these specimens. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay.

DRUG

Trastuzumab

8 mg/kg IV loading dose, followed by 6 mg /kg IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks

DRUG

Pertuzumab

840 mg IV loading dose, followed by 420 IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks

Trial Locations (7)

23230

Virginia Cancer Institute, Richmond

33705

Florida Cancer Specialists, St. Petersburg

33916

Florida Cancer Specialists, Fort Myers

37023

Tennessee Oncology, PLLC, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

45242

Oncology Hematology Care, Inc., Cincinnati

76104

Center for Cancer and Blood Disorders, Fort Worth

All Listed Sponsors
collaborator

Prometheus Laboratories

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER