National Cancer Institute
U.S. National Institutes of Health | www.cancer.gov

NCI Home
Cancer Topics
Clinical Trials
Cancer Statistics
Research & Funding
News
About NCI
Clinical Trials (PDQ®)
Patient Version   Health Professional Version
Page Options
Print This Page
E-Mail This Document
Quick Links
Director's Corner

Dictionary of Cancer Terms

NCI Drug Dictionary

Funding Opportunities

NCI Publications

Advisory Boards and Groups

Science Serving People

Español
NCI Highlights
Virtual and Standard Colonoscopy Both Accurate

Denosumab May Help Prevent Bone Loss

Past Highlights
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer (CLEOPATRA)

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


Pharmaceutical / Industry


TOC4129g
WO20698, NCT00567190

Trial Description

Summary

This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial. Patients who have HER2-positive MBC and have not received chemotherapy or biologic therapy (including approved or investigational tyrosine kinase/ HER inhibitors or vaccines) for their metastatic disease are eligible for study. Patients could have received one prior hormonal treatment for MBC. Patients may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the patient has experienced a DFI of ≥ 12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Patients may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Patients with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; patients with de-novo Stage IV disease are eligible)
  • HER2-positive metastatic breast cancer (MBC)
  • Age ≥ 18 years
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline (within 42 days of randomization)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment
  • Signed, written informed consent obtained prior to any study procedure

Exclusion Criteria:

  • History of anticancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)
  • History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting
  • History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of < 12 months
  • History of persistent Grade ≥ 2 hematologic toxicity resulting from previous adjuvant therapy
  • Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade ≥ 3 at randomization
  • History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Current clinical or radiographic evidence of central nervous system (CNS) metastases
  • CT or MRI scan of the brain is mandatory in cases of clinical suspicion of brain metastases
  • History of exposure to cumulative doses of anthracyclines
  • Current uncontrolled hypertension or unstable angina
  • History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction within 6 months of randomization
  • History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy
  • Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
  • Inadequate organ function within 28 days prior to randomization
  • Current severe, uncontrolled systemic disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
  • Pregnant or lactating women
  • History of receiving any investigational treatment within 28 days of randomization
  • Current known infection with HIV, HBV, or HCV
  • Receipt of IV antibiotics for infection within 14 days of randomization
  • Current chronic daily treatment with corticosteroids (excluding inhaled steroids)
  • Known hypersensitivity to any of the study drugs
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Trial Contact Information

Trial Lead Organizations/Sponsors

Genentech Incorporated

F. Hoffmann - La Roche, Limited

Virginia Paton, Pharm.D.Study Director

Trial Information Support LinePh: 888-662-6728 Ext.4

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
 Patti Saenz Ph: 480-496-2409
  Email: psaenz@smssouth.com
Arkansas
  Jonesboro
 NEA Medical Clinic - East Matthews
 Dawn Smith Ph: 870-934-5343
  Email: d_smith@neaclinic.com
California
  Bakersfield
 Comprehensive Blood and Cancer Center
 Julie Leach Ph: 661-862-7178
  Email: jleach@cbccusa.com
  Beverly Hills
 Tower Cancer Research Foundation
 Wendy Sabbah Ph: 310-205-5703
  Email: sabbahw@toweroncology.com
  Campbell
 Southbay Oncology / Hematology Medical Group
 Marta Roeder Ph: 408-376-2310
  Email: marta@sbohp.com
  Fountain Valley
 Compassion Cancer Care Med Grp
 Elena Zelaya Ph: 714-210-2300 Ext.220
  Email: elena.zelaya@clinicaidusa.com
 Pacific Coast Hematology/Oncology Medical Group, Incorporated
 Catherine Etheredge Ph: 714-845-0211
  Email: cetheredge@pchomg.net
  Los Angeles
 Kenmar Research
 Aileen Tamura Ph: 213-989-1888
  Email: AileenT@kenmarresearch.com
  Modesto
 Sutter Gould Medical Foundation
 Kristen Moorman Ph: 209-521-6097 Ext.3282
  Email: moormak@sutterhealth.org
  Pleasant Hill
 Bay Area Cancer Research Group, LLC - Pleasant Hill
 Mary Milligan Ph: 925-676-4740
  Email: mmilligan@bacrg.com
  San Diego
 Southern CA Permanente Med Grp
 Sharon Cory Ph: 619-641-4689
  Email: sharon.k.cory@kp.org
  Vallejo
 Kaiser Permanente Med Ctr
 Desiree Goldstein Ph: 707-651-2797
  Email: desiree.goldstein@kp.org
Florida
  Boca Raton
 Comprehensive Cancer Care
 Linda Hamilton Ph: 561-883-7503
  Email: lhamilton@lrccw.com
  Coral Springs
 NW Oncology & Hematology
 Alisha Stein Ph: 561-477-2759
  Email: astein@crninc.org
  Fort Myers
 Florida Cancer Specialists
 Cara O'Keefe Ph: 239-274-9930
  Email: cokeefe@flcancer.com
  Gainsville
 Robert R. Carroll, MD, PA - Pr
 Barbara Hitchingham Ph: 352-331-1747
  Email: barbarah@robertrcarrollmd.com
  Hollywood
 Memorial Cancer Institute at Memorial Regional Hospital
 Gertrude Roth Ph: 954-987-2020 Ext.2796
  Email: groth@mhs.net
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Robin Stewart Ph: 863-904-1877
  Email: robin.stewart@lrmc.com
  Orlando
 Florida Hospital Cancer Institute
 Bonnie Dykeman Ph: 407-303-2090
  Email: Bonnie.Dykeman@FLHOSP.ORG
  Tampa
 Bay Area Oncology
 Julie Hahn Ph: 813-875-2300 Ext.28
  Email: jhahn@bayareaoncology.com
Georgia
  Gainesville
 Oncology Specialists of North
 Patti Rotunda Ph: 770-533-8826
  Email: patti.rotunda@nghs.com
  Marietta
 Northwest Georgia Oncology Centers, PC - Marietta Center
 Mary Gilley Ph: 770-281-5131
  Email: mgilley@ngoc.com
Illinois
  Naperville
 Hematology Oncology Consultants - Naperville
 Barbara Barhamand Ph: 630-369-1501
  Email: bbarhamand@yahoo.com
  Quincy
 Cancer Ctr at Blessing Hosp
 Christina Topp Ph: 217-277-3500 Ext.7781
  Email: ctopp@quincymedgroup.com
  Zion
 Cancer Treatment Centers of America at Midwestern Regional Medical Center
 Joy Jardinico Ph: 847-731-4143
  Email: Joy.Jardinico@CTCA-hope.com
Indiana
  Indianapolis
 Hematology Oncology of Indiana, PC - Indianapolis
 Daphne Johnson Ph: 317-415-6658
  Email: research@hemoncindy.com
  Munster
 Monroe Medical Associates
 Mary Shields Ph: 219-852-6454
  Email: mshields@comhs.org
  Vincennes
 Family Medicine of Vincennes Clinical Trial Center
 Darlene Resler Ph: 812-895-8009
  Email: dreslerfmv@sbcglobal.net
Kansas
  Westwood
 Univ of Kansas Medical Center
 Jo Ann Bair Ph: 913-588-1886
  Email: jbair@kumc.edu
  Wichita
 Cancer Center of Kansas, PA - Wichita
 Jo Young Ph: 316-613-4318
  Email: youngjm@cancercenterofkansas.com
Kentucky
  Louisville
 Kentuckiana Cancer Institute, PLLC
 Leslie Haysley Ph: 502-561-8200
  Email: lhaysley@kci.us
Louisiana
  Lafayette
 Acadiana Medical Oncology
 Rebecca Donahue Ph: 337-232-2520
  Email: rbdnpaocn@aol.com
  Shreveport
 CHRISTUS Schumpert Health Syst
 Ryan Wilkerson Ph: 381-681-6007
  Email: ryan.wilkerson@christushealth.org
Maryland
  Bethesda
 Dr Carolyn B Hendricks, MD, PA
 Jennifer Dunphy Ph: 301-897-1503
  Email: Dunphymadc@yahoo.com
Massachusetts
  Pittsfield
 Berkshire Hematology Oncology, PC
 Gloria Gero Ph: 413-496-8205
  Email: gloria.gero@berkshirehemonc.com
Michigan
  Grand Rapids
 Cancer and Hematology Centers of Western Michigan, PC - Grand Rapids
 Pam Bartlett Ph: 616-977-4878
  Email: pbartlett@chcwm.com
  Saint Joseph
 Oncology Care Associates PLLC
 Nickel Kris Ph: 269-985-0029 ext 126
  Email: krisnickel@oncology-care.com
Minnesota
  Edina
 Fairview Southdale Hospital
 Kate Boulanger Ph: 952-836-3608
  Email: mboulan1@fairview.org
  Saint Louis Park
 CCOP - Metro-Minnesota
 Laura Bosshardt Ph: 952-993-1555
  Email: laura.bosshardt@parknicollet.com
Nebraska
  Lincoln
 Southeast Nebraska Cancer Center
 Lindsay Clements Ph: 402-327-7363
  Email: lindsayc@senhoc.com
  Omaha
 Hematology/Onc Consultants PC
 Amy Peterson Ph: 402-572-3511
  Email: apeterson@hocdocs.com
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 Jaya Kamath Ph: 702-384-0013
  Email: j.kamath@sncrf.org
New Jersey
  Denville
 Oncology and Hematology Specialists, PA at Saint Clare's Hospital
 Bridget Saggese Ph: 973-316-1703
  Email: bsaggese@optonline.net
  Livingston
 St. Barnabas Medical Center Cancer Center
 Rosa Gonzalez Ph: 973-322-5172
  Email: rogonzalez@SBHCS.com
New Mexico
  Farmington
 San Juan Oncology Associates, PC
 Rosemarie Mestas Ph: 505-599-6049
  Email: rmestas@sjrmc.net
New York
  Elmhurst
 Elmhurst Hospital Center
 Noreen Dawkins Ph: 718-334-3723
  Email: dawkinsn@nychhc.org
  New York
 Women's Oncology and Wellness Practice
 Amanda Ruud Ph: 212-400-4904
  Email: amandaruud@thewomenspractice.md
  Rochester
 Interlake Foundation, Inc.
 Debbie Smith Ph: 585-350-2300
  Email: debsmith02@frontiernet.net
North Carolina
  Hickory
 Carolina Oncology Spec-PA
 Sylvia McLendon Ph: 828-324-9550 Ext.222
  Email: sylviamclendonncoh@hotmail.com
Ohio
  Canton
 Gabrail Cancer Center - Canton Office
 Carrie Smith Ph: 330-492-3345 Ext.208
  Email: csmith@gabrailcancercenter.com
  Cincinnati
 Oncology Hematology Care, Incorporated - Blue Ash
 Ann Bradley Ph: 513-891-4800 Ext.3551
  Email: abradley@ohcmail.com
  Columbus
 Hematology Oncology Consultants, Incorporated
 Debbie Copley Ph: 614-846-0044 ext 3104
  Email: debbie@hoci.org
 Mid Ohio Onc Hematology Inc
 Nancy Merriman Ph: 614-383-6236
  Email: NMerriman@zangcenter.com
Oklahoma
  Oklahoma City
 OK Oncology & Hematology PC
 Christina Caldwell Ph: 405-748-8832
  Email: christina.caldwell@cancercareokla.com
  Tulsa
 Cancer Care Associates - Saint Francis Campus
 Sharon Franklin Ph: 918-499-2071
  Email: Sharon.Franklin@cancercareokla.com
Pennsylvania
  Kittanning
 Richard G. Laube Cancer Center at ACMH
 Dana Klingensmith Ph: 724-543-8699
  Email: klingensmithd@acmh.org
  Pittsburgh
 Univ of Pittsburgh Cancer Inst
 Carol Kagemann Ph: 412-641-2588
  Email: kagemannca@upmc.edu
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Janet Mari Ph: 401-274-1122 Ext.2839
  Email: jmari@wihri.org
Tennessee
  Bristol
 Blue Ridge Medical Specialists, PC
 Tracy Bowman Ph: 423-968-2311
  Email: tracebowman@charter.net
  Chattanooga
 Chattanooga Oncology and Hematology Associates
 Melissa Claxton Ph: 423-698-1844
  Email: melissaclaxton@cohaonline.com
  Germantown
 Jones Clinic - Germantown
 Lori Lynch Ph: 901-685-5969 Ext.322
  Email: llynch@jonescancerclinic.com
  Johnson City
 McLeod Blood and Cancer Center
 Annette Forgey Ph: 423-926-3611
  Email: maforgey@hotmail.com
  Nashville
 Sarah Cannon Cancer Center at Centennial Medical Center
 Jennifer Thompson Ph: 615-329-7252
  Email: jennifer.thompson@scresearch.net
Texas
  Houston
 Oncology Consultants - Memorial City
 Patty Paquette Ph: 713-275-3205
  Email: research@oncologyconsultants.com
  San Antonio
 South Texas Oncology and Hematology - North San Saba
 Katherine DeLeon Ph: 210-288-1437
  Email: katherine.deleon@stoh.com
Utah
  Ogden
 Utah Hematology Oncology, PC
 Shirley Waters Ph: 801-387-7166
  Email: nua@ihc.com
Vermont
  Rutland
 Community Cancer Center
 Rebecca Denofer Ph: 802-747-1692
  Email: rdenofer@rrmc.org
Washington
  Walla Walla
 St. Mary Regional Cancer Center at St. Mary Medical Center
 Cheri Adams Ph: 509-522-5993
  Email: AdamCh@smmc.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00567190
Information obtained from ClinicalTrials.gov on August 11, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to Top

A Service of the National Cancer Institute
Department of Health and Human Services National Institutes of Health USA.gov