A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
CLEOPATRA
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
3 other identifiers
interventional
808
26 countries
322
Brief Summary
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2008
Longer than P75 for phase_3
322 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedStudy Start
First participant enrolled
February 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2011
CompletedResults Posted
Study results publicly available
September 13, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedDecember 13, 2019
December 1, 2019
3.2 years
December 3, 2007
August 14, 2012
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Determined by an Independent Review Facility
PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of ≥1 new lesion. For non-target lesions, PD was defined as the appearance of ≥1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.
Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)
Secondary Outcomes (16)
Overall Survival
From randomization to death from any cause, up to each respective analysis data cut-off date (see the Description field for the median time on study per treatment arm)
Progression-Free Survival (PFS) Determined by the Investigator
Tumor assessments every 9 weeks from randomization to investigator-determined PD or death from any cause, whichever occurred first (median [range] time on study in pertuzumab vs. placebo arms: 201.8 [0.7-520.0] weeks vs. 138.0 [0.4-514.7] weeks)
Objective Response Determined by an Independent Review Facility
Tumor assessments every 9 weeks from Baseline until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)
Duration of Objective Response Determined by an Independent Review Facility
From initial IRF-confirmed objective response until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)
Time to Symptom Progression
Every 9 weeks from Baseline until investigator-determined progressive disease, up to the primary completion date (up to 3 years, 3 months)
- +11 more secondary outcomes
Study Arms (2)
Pertuzumab + Trastuzumab + Docetaxel
EXPERIMENTALParticipants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
Placebo + Trastuzumab + Docetaxel
PLACEBO COMPARATORParticipants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
Interventions
Pertuzumab was administered as an intravenous (IV) loading dose of 840 milligrams (mg) q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420 mg q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Placebo (matching pertuzumab) was administered intravenously.
Trastuzumab was administered as an IV loading dose of 8 milligrams per kilogram (mg/kg) q3w on Day 2 of Cycle 1 (1 Cycle length = 21 days), and 6 mg/kg q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Docetaxel was administered as an IV dose of 75 milligrams per square meter of body surface area (mg/m\^2) q3w on Day 2 of Cycle 1 (1 Cycle length = 21 days), and 75 mg/m\^2 (up to 100 mg/m\^2 as per treating physician discretion) q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. On or prior to Cycle 6, docetaxel was only to be discontinued for progressive disease or unmanageable toxicity. After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Participants with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; participants with de novo Stage IV disease are eligible)
- Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC)
- Left ventricular ejection fraction (LVEF) ≥50 percent (%) at baseline (within 42 days of randomization)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment
You may not qualify if:
- History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC, which must be stopped prior to randomization)
- 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 less than (\<)12 months
- History of persistent Grade ≥2 hematologic toxicity resulting from previous adjuvant therapy
- Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria for Adverse Events (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, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent
- Current clinical or radiographic evidence of central nervous system (CNS) metastases
- Computed tomography (CT) or magnetic resonance imaging (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 congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception: atrial fibrillation or paroxysmal supraventricular tachycardia)
- 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, as defined in the protocol, within 28 days prior to randomization
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (322)
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, 85258, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Central Hematology Oncology Medical Group Inc.
Alhambra, California, 91801, United States
Pacific Cancer Medical Center
Anaheim, California, 92801, United States
Comprehensive Blood/Cancer Ctr
Bakersfield, California, 93309, United States
Kaiser Permanente - Baldwin Park
Baldwin Park, California, 91706, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
South Bay Oncology Hematology Partners
Campbell, California, 95008, United States
Wilshire Oncology Medical Group
Corona, California, 92879, United States
Compassionate Cancer Care
Fountain Valley, California, 92708, United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708, United States
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, 92835, United States
Wilshire Onc Med Grp., Inc
Glendora, California, 91741, United States
Wilshire Oncology Medical Group
La Verne, California, 91750, United States
UCLA
Los Angeles, California, 90024, United States
LAC USC Medical Center
Los Angeles, California, 90033, United States
Cedars- Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center Clin Lab
Los Angeles, California, 90095, United States
TORI Central Administration
Los Angeles, California, 90095, United States
UCLA Hematology / Oncology Clinic
Los Angeles, California, 90095, United States
UCLA Med Ctr; Pharma Svcs
Los Angeles, California, 90095, United States
Sutter Gould Medical Foundation; Clinical Research
Modesto, California, 95355, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
UCLA Healthcare/Pasadena Oncology
Pasadena, California, 91105, United States
Wilshire Oncology Medical Group
Pasadena, California, 91750, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523, United States
Wilshire Oncology Medical Group
Pomona, California, 91767, United States
Wilshire Oncology Medical Group
Rancho Cucamonga, California, 91730, United States
UC Davis Cancer Center; Oncology
Sacramento, California, 95817, United States
Kaiser Permanente San Diego; Hepatology Research
San Diego, California, 92154, United States
K. Permanente - San Fransisco
San Francisco, California, 94115, United States
K. Permanente - San Jose
San Jose, California, 95119, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
UCLA Hematology/Oncology
Santa Monica, California, 90404, United States
UCLA / Santa Clarita Valley Cancer Center
Valencia, California, 91355, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
K. Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
Wilshire Oncology Medical Group
West Covina, California, 91790, United States
Innovative clinical research institute/American institute of research
Whittier, California, 90603, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hosp Center
Washington D.C., District of Columbia, 20010, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33428, United States
Florida Cancer Specialists -Cape Coral (Cape Coral Pkwy)
Cape Coral, Florida, 33914, United States
Florida Cancer Specialists - Cape Coral (Del Prado Blvd)
Cape Coral, Florida, 33990, United States
Northwest Oncology/ Hematology Assoc.
Coral Springs, Florida, 33065-5701, United States
UM Sylvester Deerfield Beach; Sylvester Cancer Ctr
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists - Englewood
Englewood, Florida, 34223, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers, Florida, 33901-8101, United States
Florida Cancer Specialists - Broadway
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists-Broadway, Fort Myers
Fort Myers, Florida, 33908, United States
Private Practice Robert R. Carroll, Md, Pa
Gainesville, Florida, 32605, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33804-1057, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Florida Cancer Specialists - Goodlette, Naples
Naples, Florida, 34102, United States
Florida Cancer Specialists - Pine Ridge, Naples
Naples, Florida, 34119, United States
Private Practice
Orlando, Florida, 32804, United States
Breast Cancer Centre at Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Florida Cancer Specialists - Port Charlotte
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists; Sarasota
Sarasota, Florida, 34232, United States
Bay Area Oncology
Tampa, Florida, 33607, United States
Florida Cancer Specialists - Venice (S. Tamiami Tr)
Venice, Florida, 33980, United States
Florida Cancer Specialists - Sunset Lake, Venice
Venice, Florida, 34292, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Northeast Georgia Medical Center; Oncology Research Dept-5C
Gainesville, Georgia, 30501, United States
Central Georgia Hematology Oncology Associates
Macon, Georgia, 31201, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, 30060, United States
Central GA Cancer Care
Warner Robins, Georgia, 31088-2259, United States
Elmhurst Hospital
Elmhurst, Illinois, 60126, United States
Hematology Oncology Consultants Ltd
Naperville, Illinois, 60540, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Midwestern Regional Medical Center; Office of Research
Zion, Illinois, 60099, United States
Monroe Medical Associates - Hobart
Hobart, Indiana, 46342, United States
St. Mary Medical Center
Hobart, Indiana, 46432, United States
Hematology-Oncology of Indiana, Pc
Indianapolis, Indiana, 46260, United States
Community Hospital; Pharmacy
Munster, Indiana, 46321, United States
Northwest Oncology
Munster, Indiana, 46321, United States
Monroe Medical Associates
Munster, Indiana, 46375, United States
Family Medicine Vincennes
Vincennes, Indiana, 47591, United States
Uni of Iowa Hospital&Clinic; Holden Comprehens. Cancer Ctr
Iowa City, Iowa, 52242, United States
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, 66205, United States
Cancer Center of Kansas
Wichita, Kansas, 67214-3728, United States
Jewish Cancer Care
Louisville, Kentucky, 40245, United States
Cancer Center of Acadiana at Lafayette General
Lafayette, Louisiana, 70506, United States
Christus Schumpert Health System
Shreveport, Louisiana, 71101-1978, United States
Private Practice- Carolyn Hendricks, MD
Bethesda, Maryland, 20817, United States
Boston Medical Center
Boston, Massachusetts, 02118-2393, United States
Berkshire Hematology, Oncology Pc
Pittsfield, Massachusetts, 01201, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Cancer & Hematology Center of West Michigan
Grand Rapids, Michigan, 49546, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
Edina, Minnesota, 55435, United States
US Oncology Research at Minnesota Oncology
Minneapolis, Minnesota, 55404, United States
Minneapolis Oncology Hamatology PA
Minneapolis, Minnesota, 55407-3799, United States
The Jones Clinic, PC
New Albany, Mississippi, 38652, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59101, United States
Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
Lincoln, Nebraska, 68510, United States
Norfolk Oncology Consultants
Norfolk, Nebraska, 68701, United States
Hematology-Oncology Consultants, Pc
Omaha, Nebraska, 68122, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
St. Barnabas Cancer Center
Livingston, New Jersey, 07039, United States
Oncology and Hematology Specialists
Mountain Lakes, New Jersey, 07046, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Brockport-Interlakes Foundation
Brockport, New York, 14420, United States
Canandaigua-Interlakes Found
Canandaigua, New York, 14420, United States
Geneva-Interlakes Foundation
Geneva, New York, 14456, United States
ProHEALTH Care Associates LLP
Lake Success, New York, 11042, United States
Beth Israel Comprehensive Cancer Center Pharmacy
New York, New York, 10011, United States
The Women'sOncology & Wellness Practice
New York, New York, 10016, United States
Upstate Ny Cancer Research & Education Foundation
Rochester, New York, 14623, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, 28602, United States
Carolina BioOncology Institute, PLCC
Huntersville, North Carolina, 28078, United States
NW Carolina Onc & Hem
Lenoir, North Carolina, 28645, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Hema Onc Conslts-Grant Ave
Columbus, Ohio, 43215, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
Columbus, Ohio, 43219, United States
Hematology Onc Consultants
Columbus, Ohio, 43228, United States
Gabrail Cancer Center
Dover, Ohio, 44622, United States
Hematology Oncology Consultants (NWK)
Granville, Ohio, 43023, United States
Medical College of Ohio; Cancer Institute
Toledo, Ohio, 43614, United States
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, 73120, United States
CA Care Associates-OK Oncology and Hematology
Tulsa, Oklahoma, 74104, United States
Cancer Care Assoc-S. Ingo
Tulsa, Oklahoma, 74133, United States
OK Oncology & Hematology PC
Tulsa, Oklahoma, 74136, United States
Cons in Med Onc and Hem
Darby, Pennsylvania, 19026, United States
Consultants in Medical Oncology/Hematology
Drexel Hill, Pennsylvania, 19026, United States
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201, United States
Conslts in Med Onc (Newtown); Bryn Mawr Health Canc Ctr
Newtown Square, Pennsylvania, 19073, United States
Uni of Pittsburgh; Magee-Women'S Hospital
Pittsburgh, Pennsylvania, 15213, United States
Consultants Med Onc & Hem
Ridley Park, Pennsylvania, 19078, United States
Erlanger Health System; Oncology Research
Chattanooga, Tennessee, 37403, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
McLeod Cancer and Blood Center
Johnson City, Tennessee, 37604, United States
University of Tennessee Cancer Institute;Hem-Onc Consultants
Knoxville, Tennessee, 37920, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, 37203, United States
Park Plaza
Houston, Texas, 77004, United States
Southwest
Houston, Texas, 77008, United States
St. Joseph's
Houston, Texas, 77008, United States
Memorial City-Main Office
Houston, Texas, 77024, United States
Oncology Consultants
Houston, Texas, 77024, United States
St. Luke's
Houston, Texas, 77030, United States
Willowbrook
Houston, Texas, 77070, United States
Katy-Christus St. Catherine
Katy, Texas, 77450, United States
South Texas Oncology Hematology
San Antonio, Texas, 78258, United States
Oncology Consultants - Sugar Land
Sugar Land, Texas, 77479, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Community Cancer Center Rutland Regional Medical Center
Rutland, Vermont, 05701, United States
Wellmonth Physician Services
Bristol, Virginia, 24201, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
St. Mary Medical Center
Walla Walla, Washington, 99362, United States
Sanatorio Güemes; Oncología
Buenos Aires, 1180, Argentina
Centro de Oncologia e Investigacion Buenos Aires (COIBA)
Buenos Aires, B1884BBF, Argentina
Instituto Medico Especializado (IME); Oncologia
Caba, 1405, Argentina
Center Instituto Médico Privado I.M.P.; Oncology
Chaco-resistencia, 3400, Argentina
Policlinica Privada Site la Plata SA; Oncology
La Plata, B1902CMK, Argentina
Unidad Oncológica De Neuquén
Neuquén, Q8300HDH, Argentina
Hosp Provincial D. Centenarios; Oncology Dept
Rosario, S2002KDS, Argentina
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550, Brazil
Clinica Amo - Assistencia Medica Em Oncologia
Salvador, Estado de Bahia, 41950-610, Brazil
Centro Goiano de Oncologia - CGO
Goiânia, Goiás, 74140-050, Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ; Oncologia
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Hospital das Clinicas - FMUSP Ribeirao Preto
Ribeirão Preto, São Paulo, 14048-900, Brazil
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santo André, São Paulo, 09060-650, Brazil
Iso - Inst. Santista de Oncologia
Santos, São Paulo, 11075-350, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho - ICAVC; Pesquisa Clinica
São Paulo, São Paulo, 01221-020, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia
São Paulo, São Paulo, 03102-002, Brazil
Hospital Estadual do Servidor Publico
São Paulo, São Paulo, 04039-901, Brazil
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, São Paulo, 18030-005, Brazil
St. Michael'S Hospital
Toronto, Ontario, M5B 1W8, Canada
Jilin Cancer Hospital
Changchun, 130012, China
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, 110016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Shanghai First People's Hospital
Shanghai, 200080, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Hospital Cima San Jose; Oncology
San José, 10103, Costa Rica
Clinical Hospital Sisters of Mercy
Zagreb, 10000, Croatia
University Hospital Centre Zagreb; Clinic For Oncology
Zagreb, 10000, Croatia
Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology
Guayaquil, EC090112, Ecuador
Teodoro Maldonado Carbo Hospital; Oncology Service
Guayaquil, EC090150, Ecuador
Hospital Carlos Andrade Marin; Servicio de Oncología
Quito, 2569, Ecuador
Hospital Solca Quito; Oncologia
Quito, EC170124, Ecuador
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, 20520, Finland
Centre Oncologie Du Pays Basque
Bayonne, 64100, France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, 33000, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Jean Bernard
Le Mans, 72015, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189, France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805, France
Groupe Hospitalier Sud; Oncologie Radiotherapie
Salouël, 80480, France
Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
Berlin, 14195, Germany
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
Bielefeld, 33604, Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, 50935, Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, 45122, Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, 20246, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131, Germany
Krankenhaus Rheinfelden; Frauenklinik
Rheinfelden, 79618, Germany
Robert-Bosch-Krankenhaus; Hämatologie, Onkologie und Palliativmedizin
Stuttgart, 70376, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, 54290, Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, 72076, Germany
Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek
Würselen, 52146, Germany
Centro Oncologico S.A.
Guatemala City, 01010, Guatemala
Grupo Angeles
Guatemala City, 01015, Guatemala
Therapeutic Research Inst. & Lab S.A. (Trial)
Guatemala City, 01015, Guatemala
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong, Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, Hong Kong
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
Chieti, Abruzzo, 66100, Italy
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, 72100, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
Ospedale Provinciale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48100, Italy
Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia
Frosinone, Lazio, 03100, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, 10060, Italy
Ospedale Di Macerata; Oncologia
Macerata, The Marches, 62100, Italy
Azienda Sanitaria S. Maria Annunziata; S. C. Oncologia Medica
Antella (FI), Tuscany, 50011, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, 59100, Italy
Aichi Cancer Center Hospital, Breast Oncology
Aichi, 464-8681, Japan
Chiba Cancer Center; Breast Surgical Oncology
Chiba, 260-8717, Japan
National Cancer Center Hospital East; Breast and Medical Oncology
Chiba, 277-8577, Japan
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
Ehime, 791-0280, Japan
Kitakyushu Municipal Medical Center, Surgery
Fukuoka, 802-0077, Japan
National Hospital Organization Kyushu Cancer Center;Breast Oncology
Fukuoka, 811-1395, Japan
Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery
Gunma, 371-8511, Japan
Sagara Hospital; Breast Surgery
Kagoshima, 892-0833, Japan
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
Kanagawa, 216-8511, Japan
Tokai University Hospital, Breast and Endocrine Surgery
Kanagawa, 259-1193, Japan
Kumamoto City Hospital, Breast and Endocrine Surgery
Kumamoto, 862-8505, Japan
Kumamoto Shinto General Hospital; Breast Cancer Center
Kumamoto, 862-8655, Japan
Kyoto University Hospital; Breast Surgery
Kyoto, 606-8507, Japan
Niigata Cancer Ctr Hospital; Breast Surgery
Niigata, 951-8566, Japan
Iwate Med Univ School of Med; Surgery
Numakunai, 020-8505, Japan
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
Osaka, 534-0021, Japan
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, 540-0006, Japan
Osaka University Hospital; Breast and Endocrine Surgery
Osaka, 565-0871, Japan
Saitama Medical University International Medical Center; Medical Oncology
Saitama, 350-1298, Japan
Saitama Cancer Center, Breast Oncology
Saitama, 362-0806, Japan
Shizuoka Cancer Center; Female Internal Medicine
Shizuoka, 411-8777, Japan
Shizuoka General Hospital; Breast Surgery
Shizuoka, 420-8527, Japan
Jichi Medical University; Dept of Clinical Oncology
Tochigi, 329-0498, Japan
National Cancer Center Hospital; Breast and Medical Oncology
Tokyo, 104-0045, Japan
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo, 104-8560, Japan
Tokyo Metropolitan; Komagome Hospital, Surgery
Tokyo, 113-8677, Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, 135-8550, Japan
Tokyo Medical Uni. Hospital; Breast Oncology
Tokyo, 160-0023, Japan
Daugavpils Regional Hospital
Daugavpils, 5417, Latvia
Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
Riga, LV 1079, Latvia
P.Stradins Clinical University Hospital, Oncology Centre
Riga, LV-1002, Latvia
Hospital Angeles Metropolitano; Room 220
Mexico City, Mexico CITY (federal District), 06760, Mexico
Centro Oncologico Estatal ISSEMYM
Toluca, 50180, Mexico
Clinical Hospital; Oncology Department
Bitola, 7000, North Macedonia
Institute of Radiotherapy Oncology
Skopje, 1000, North Macedonia
Private Health Organization Acibadem Sistina Hospital
Skopje, 1000, North Macedonia
Cebu Cancer Institute; Perpetual Succour Hospital
Cebu City, 6000, Philippines
Veterans Memorial Medical Center; Oncology
Quezon City, 1101, Philippines
St Luke'S Medical Centre; Oncology
Quezon City, 1114, Philippines
Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej
Lublin, 20-081, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090, Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, 60-569, Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, 71-730, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781, Poland
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Regional Oncology Hospital Of Kursk; Chemotherapy
Kislino, Kursk Region, 305524, Russia
Blokhin Cancer Research Center; Combined Treatment
Moscow, 115478, Russia
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, 115478, Russia
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
Omsk, 644013, Russia
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg, 460021, Russia
SBI of Healthcare Leningrad Regional Oncology Dispensary
Saint Petersburg, 191104, Russia
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228, Singapore
National Cancer Centre; Medical Oncology
Singapore, 169610, Singapore
National Cancer Center; Medical Oncology
Gyeonggi-do, 410-769, South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.
Seoul, 120-752, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, 138-736, South Korea
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, 15006, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Duran i Reynals; Oncologia
Barcelona, 08907, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, 25198, Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, 28033, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330, Thailand
National Cancer Inst.
Bangkok, 10400, Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok, 10400, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla, 90110, Thailand
Broomfield Hospital; Oncology
Chelmsford, CM1 7ET, United Kingdom
St James Uni Hospital; Icrf Cancer Medicine Research Unit
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW, United Kingdom
St. Bartholomew'S Hospital; Dept of Medical Oncology
London, EC1A 7BE, United Kingdom
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
St George'S Hospital; Oncology Research Office /Oncology Opd
London, SW17 ORE, United Kingdom
Charing Cross Hospital; Medical Oncology.
London, W6 8RF, United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, HA6 2RN, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, TR1 3LJ, United Kingdom
Southend Hospital; Oncology Dept
Westcliffe-on-sea, SS0 0RY, United Kingdom
Related Publications (12)
Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.
PMID: 22149875RESULTSwain SM, Miles D, Kim SB, Im YH, Im SA, Semiglazov V, Ciruelos E, Schneeweiss A, Loi S, Monturus E, Clark E, Knott A, Restuccia E, Benyunes MC, Cortes J; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Apr;21(4):519-530. doi: 10.1016/S1470-2045(19)30863-0. Epub 2020 Mar 12.
PMID: 32171426DERIVEDMiles D, Im YH, Fung A, Yoo B, Knott A, Heeson S, Beattie MS, Swain SM. Effect of docetaxel duration on clinical outcomes: exploratory analysis of CLEOPATRA, a phase III randomized controlled trial. Ann Oncol. 2017 Nov 1;28(11):2761-2767. doi: 10.1093/annonc/mdx406.
PMID: 29112701DERIVEDSwain SM, Schneeweiss A, Gianni L, Gao JJ, Stein A, Waldron-Lynch M, Heeson S, Beattie MS, Yoo B, Cortes J, Baselga J. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. Ann Oncol. 2017 Apr 1;28(4):761-768. doi: 10.1093/annonc/mdw695.
PMID: 28057664DERIVEDLuen SJ, Salgado R, Fox S, Savas P, Eng-Wong J, Clark E, Kiermaier A, Swain SM, Baselga J, Michiels S, Loi S. Tumour-infiltrating lymphocytes in advanced HER2-positive breast cancer treated with pertuzumab or placebo in addition to trastuzumab and docetaxel: a retrospective analysis of the CLEOPATRA study. Lancet Oncol. 2017 Jan;18(1):52-62. doi: 10.1016/S1470-2045(16)30631-3. Epub 2016 Dec 7.
PMID: 27964843DERIVEDSwain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Heeson S, Clark E, Ross G, Benyunes MC, Cortes J; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. doi: 10.1056/NEJMoa1413513.
PMID: 25693012DERIVEDBaselga J, Cortes J, Im SA, Clark E, Ross G, Kiermaier A, Swain SM. Biomarker analyses in CLEOPATRA: a phase III, placebo-controlled study of pertuzumab in human epidermal growth factor receptor 2-positive, first-line metastatic breast cancer. J Clin Oncol. 2014 Nov 20;32(33):3753-61. doi: 10.1200/JCO.2013.54.5384. Epub 2014 Oct 20.
PMID: 25332247DERIVEDSwain SM, Baselga J, Miles D, Im YH, Quah C, Lee LF, Cortes J. Incidence of central nervous system metastases in patients with HER2-positive metastatic breast cancer treated with pertuzumab, trastuzumab, and docetaxel: results from the randomized phase III study CLEOPATRA. Ann Oncol. 2014 Jun;25(6):1116-21. doi: 10.1093/annonc/mdu133. Epub 2014 Mar 31.
PMID: 24685829DERIVEDMiles D, Baselga J, Amadori D, Sunpaweravong P, Semiglazov V, Knott A, Clark E, Ross G, Swain SM. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013 Nov;142(1):89-99. doi: 10.1007/s10549-013-2710-z. Epub 2013 Oct 16.
PMID: 24129974DERIVEDCortes J, Baselga J, Im YH, Im SA, Pivot X, Ross G, Clark E, Knott A, Swain SM. Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer. Ann Oncol. 2013 Oct;24(10):2630-2635. doi: 10.1093/annonc/mdt274. Epub 2013 Jul 17.
PMID: 23868905DERIVEDSwain SM, Kim SB, Cortes J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013 May;14(6):461-71. doi: 10.1016/S1470-2045(13)70130-X. Epub 2013 Apr 18.
PMID: 23602601DERIVEDBaselga J, Swain SM. CLEOPATRA: a phase III evaluation of pertuzumab and trastuzumab for HER2-positive metastatic breast cancer. Clin Breast Cancer. 2010 Dec 1;10(6):489-91. doi: 10.3816/CBC.2010.n.065.
PMID: 21147694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc./Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2007
First Posted
December 4, 2007
Study Start
February 12, 2008
Primary Completion
May 13, 2011
Study Completion
November 23, 2018
Last Updated
December 13, 2019
Results First Posted
September 13, 2012
Record last verified: 2019-12