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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00567190
Other study ID # TOC4129g
Secondary ID WO206982007-0029
Status Completed
Phase Phase 3
First received
Last updated
Start date February 12, 2008
Est. completion date November 23, 2018

Study information

Verified date December 2019
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 808
Est. completion date November 23, 2018
Est. primary completion date May 13, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pertuzumab
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
Placebo (matching pertuzumab) was administered intravenously.
Trastuzumab
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
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.

Locations

Country Name City State
Argentina Centro de Oncologia e Investigacion Buenos Aires (COIBA) Buenos Aires
Argentina Sanatorio Güemes; Oncología Buenos Aires
Argentina Instituto Medico Especializado (IME); Oncologia Caba
Argentina Center Instituto Médico Privado I.M.P.; Oncology Chaco-resistencia
Argentina Policlinica Privada Site la Plata SA; Oncology La Plata
Argentina Unidad Oncológica De Neuquén Neuquén
Argentina Hosp Provincial D. Centenarios; Oncology Dept Rosario
Brazil Crio - Centro Regional Integrado de Oncologia Fortaleza CE
Brazil Centro Goiano de Oncologia - CGO Goiania GO
Brazil Hospital de Caridade de Ijui; Oncologia Ijui RS
Brazil Hospital Amaral Carvalho Jau SP
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre RS
Brazil Santa Casa de Misericordia de Porto Alegre Porto Alegre RS
Brazil Hospital das Clinicas - FMUSP Ribeirao Preto Ribeirao Preto SP
Brazil Hospital Universitario Clementino Fraga Filho - UFRJ; Oncologia Rio de Janeiro RJ
Brazil Instituto Nacional de Cancer - INCa; Oncologia Rio de Janeiro RJ
Brazil Clinica Amo - Assistencia Medica Em Oncologia Salvador BA
Brazil Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia Santo Andre SP
Brazil Iso - Inst. Santista de Oncologia Santos SP
Brazil Hospital Estadual do Servidor Publico Sao Paulo SP
Brazil Hospital Perola Byington Sao Paulo SP
Brazil Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia Sao Paulo SP
Brazil Instituto do Cancer Arnaldo Vieira de Carvalho - ICAVC; Pesquisa Clinica Sao Paulo SP
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Brazil Instituto de Oncologia de Sorocaba - CEPOS Sorocaba SP
Canada St. Michael'S Hospital Toronto Ontario
China Jilin Cancer Hospital Changchun
China Fuzhou General Hospital, PLA Nanjing Military Area Command Fuzhou
China Zhejiang Cancer Hospital Hangzhou
China Shanghai First People's Hospital Shanghai
China Fudan University Shanghai Cancer Center Shanghai City
Costa Rica Hospital Cima San Jose; Oncology San Jose
Croatia Clinical Hospital Sisters of Mercy Zagreb
Croatia University Hospital Centre Zagreb; Clinic For Oncology Zagreb
Ecuador Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology Guayaquil
Ecuador Teodoro Maldonado Carbo Hospital; Oncology Service Guayaquil
Ecuador Hospital Carlos Andrade Marin; Servicio de Oncología Quito
Ecuador Hospital Solca Quito; Oncologia Quito
Finland Tampere University Hospital; Dept of Oncology Tampere
Finland Turku Uni Central Hospital; Oncology Clinics Turku
France Centre Oncologie Du Pays Basque Bayonne
France Clinique Tivoli; Sce Radiotherapie Bordeaux
France Centre Georges Francois Leclerc; Oncologie 3 Dijon
France Centre Hospitalier Departemental Les Oudairies La Roche Sur Yon
France Centre Jean Bernard Le Mans
France Centre Antoine Lacassagne; Hopital De Jour A2 Nice
France Ico Rene Gauducheau; Oncologie Saint Herblain
France Groupe Hospitalier Sud; Oncologie Radiotherapie Salouel
Germany Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch Berlin
Germany Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie Bielefeld
Germany Universitätsklinikum Essen; Zentrum Für Frauenheilkunde Essen
Germany Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie Halle
Germany Universitätsklinikum Hamburg-Eppendorf; Frauenklinik Hamburg
Germany Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg Heidelberg
Germany St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe Koeln
Germany Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde Mainz
Germany Krankenhaus Rheinfelden; Frauenklinik Rheinfelden
Germany Robert-Bosch-Krankenhaus; Hämatologie, Onkologie und Palliativmedizin Stuttgart
Germany Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie Trier
Germany Universitätsklinik Tübingen; Frauenklinik Tübingen
Germany Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek Wuerselen
Guatemala Centro Oncologico S.A. Guatemala
Guatemala Grupo Angeles Guatemala City
Guatemala Therapeutic Research Inst. & Lab S.A. (Trial) Guatemala City
Hong Kong Pamela Youde Nethersole Eastern Hospital; Clinical Oncology Hong Kong
Hong Kong Prince of Wales Hosp; Dept. Of Clinical Onc Shatin
Italy Azienda Sanitaria S. Maria Annunziata; S. C. Oncologia Medica Antella (FI) Toscana
Italy Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina Brescia Lombardia
Italy Ospedale Antonio Perrino; Oncologia Medica Brindisi Puglia
Italy Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo Candiolo Piemonte
Italy Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica Chieti Abruzzo
Italy Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia Frosinone Lazio
Italy Ospedale Di Macerata; Oncologia Macerata Marche
Italy IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna
Italy Ospedale Misericordia E Dolce; Oncologia Medica Prato Toscana
Italy Ospedale Provinciale Santa Maria delle Croci Ravenna Emilia-Romagna
Japan Aichi Cancer Center Hospital, Breast Oncology Aichi
Japan Chiba Cancer Center; Breast Surgical Oncology Chiba
Japan National Cancer Center Hospital East; Breast and Medical Oncology Chiba
Japan Natl Hosp Org Shikoku; Cancer Ctr, Surgery Ehime
Japan Kitakyushu Municipal Medical Center, Surgery Fukuoka
Japan National Hospital Organization Kyushu Cancer Center;Breast Oncology Fukuoka
Japan Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery Gunma
Japan Iwate Med Univ School of Med; Surgery Iwate
Japan Sagara Hospital; Breast Surgery Kagoshima
Japan St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery Kanagawa
Japan Tokai University Hospital, Breast and Endocrine Surgery Kanagawa
Japan Kumamoto City Hospital, Breast and Endocrine Surgery Kumamoto
Japan Kumamoto Shinto General Hospital; Breast Cancer Center Kumamoto
Japan Kyoto University Hospital; Breast Surgery Kyoto
Japan Niigata Cancer Ctr Hospital; Breast Surgery Niigata
Japan National Hospital Organization Osaka National Hospital; Breast Surgery Osaka
Japan OSAKA CITY GENERAL HOSPITAL;Medical Oncology Osaka
Japan Osaka University Hospital; Breast and Endocrine Surgery Osaka
Japan Saitama Cancer Center, Breast Oncology Saitama
Japan Saitama Medical University International Medical Center; Medical Oncology Saitama
Japan Shizuoka Cancer Center; Female Internal Medicine Shizuoka
Japan Shizuoka General Hospital; Breast Surgery Shizuoka
Japan Jichi Medical University; Dept of Clinical Oncology Tochigi
Japan National Cancer Center Hospital; Breast and Medical Oncology Tokyo
Japan St. Luke's Internat. Hospital, Breast Surgical Oncology Tokyo
Japan The Cancer Inst. Hosp. of JFCR; Breast Oncology Center Tokyo
Japan Tokyo Medical Uni. Hospital; Breast Oncology Tokyo
Japan Tokyo Metropolitan; Komagome Hospital, Surgery Tokyo
Korea, Republic of National Cancer Center; Medical Oncology Gyeonggi-do
Korea, Republic of Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology Seoul
Korea, Republic of Samsung Medical Centre; Division of Hematology/Oncology Seoul
Korea, Republic of Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology Seoul
Korea, Republic of Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept. Seoul
Latvia Daugavpils Regional Hospital Daugavpils
Latvia P.Stradins Clinical University Hospital, Oncology Centre Riga
Latvia Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs Riga
Mexico Hospital Angeles Metropolitano; Room 220 Mexico City Mexico CITY (federal District)
Mexico Centro Oncologico Estatal ISSEMYM Toluca
North Macedonia Clinical Hospital; Oncology Department Bitola
North Macedonia Institute of Radiotherapy Oncology Skopje
North Macedonia Private Health Organization Acibadem Sistina Hospital Skopje
Philippines Cebu Cancer Institute; Perpetual Succour Hospital Cebu City
Philippines St Luke'S Medical Centre; Oncology Quezon City
Philippines Veterans Memorial Medical Center; Oncology Quezon City
Poland COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej Lublin
Poland Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej Lublin
Poland Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu Poznan
Poland Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych Szczecin
Poland Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii Warszawa
Russian Federation Ivanovo Regional Oncology Dispensary Ivanovo
Russian Federation Regional Oncology Hospital Of Kursk; Chemotherapy Kislino, Kursk Region
Russian Federation Blokhin Cancer Research Center; Combined Treatment Moscow
Russian Federation Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy Moscow
Russian Federation Omsk Region Clinical Oncology Dispensary; 1St Sergical Department Omsk
Russian Federation State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis Orenburg
Russian Federation SBI of Healthcare Samara Regional Clinical Oncology Dispensary Samara
Russian Federation FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF St Petersburg Leningrad
Russian Federation SBI of Healthcare Leningrad Regional Oncology Dispensary St Petersburg
Singapore National Cancer Centre; Medical Oncology Singapore
Singapore National University Hospital; National University Cancer Institute, Singapore (NCIS) Singapore
Spain Hospital Duran i Reynals; Oncologia Barcelona
Spain Hospital Univ Vall d'Hebron; Servicio de Oncologia Barcelona
Spain Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen
Spain Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología La Coruña
Spain Hospital Universitario de Canarias;servicio de Oncologia La Laguna Tenerife
Spain Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia Lerida
Spain Centro Oncologico MD Anderson Internacional; Servicio de Oncologia Madrid
Spain Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid
Spain Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Malaga
Thailand Chulalongkorn Hospital; Medical Oncology Bangkok
Thailand Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Bangkok
Thailand National Cancer Inst. Bangkok
Thailand Rajavithi Hospital; Division of Medical Oncology Bangkok
Thailand Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Bangkok
Thailand Songklanagarind Hospital; Department of Oncology Songkhla
United Kingdom Broomfield Hospital; Oncology Chelmsford
United Kingdom St James Uni Hospital; Icrf Cancer Medicine Research Unit Leeds
United Kingdom Leicester Royal Infirmary; Dept. of Medical Oncology Leicester
United Kingdom Charing Cross Hospital; Medical Oncology. London
United Kingdom Royal Free Hospital; Dept of Oncology London
United Kingdom St George'S Hospital; Oncology Research Office /Oncology Opd London
United Kingdom St. Bartholomew'S Hospital; Dept of Medical Oncology London
United Kingdom Mount Vernon Hospital; Centre For Cancer Treatment Northwood
United Kingdom Royal Cornwall Hospital; Dept of Clinical Oncology Truro
United Kingdom Southend Hospital; Oncology Dept Westcliffe-on-sea
United Kingdom The Clatterbridge Cancer Ctr For Oncolgy Wirral
United States Central Hematology Oncology Medical Group Inc. Alhambra California
United States Pacific Cancer Medical Center Anaheim California
United States Comprehensive Blood/Cancer Ctr Bakersfield California
United States Kaiser Permanente - Baldwin Park Baldwin Park California
United States Private Practice- Carolyn Hendricks, MD Bethesda Maryland
United States Tower Cancer Research Foundation Beverly Hills California
United States St. Vincent Frontier Cancer Center Billings Montana
United States Boca Raton Comprehensive Cancer Center Boca Raton Florida
United States Boston Medical Center Boston Massachusetts
United States Wellmonth Physician Services Bristol Virginia
United States Brockport-Interlakes Foundation Brockport New York
United States South Bay Oncology Hematology Partners Campbell California
United States Canandaigua-Interlakes Found Canandaigua New York
United States Gabrail Cancer Center Canton Ohio
United States Florida Cancer Specialists - Cape Coral (Del Prado Blvd) Cape Coral Florida
United States Florida Cancer Specialists -Cape Coral (Cape Coral Pkwy) Cape Coral Florida
United States Erlanger Health System; Oncology Research Chattanooga Tennessee
United States SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee
United States Oncology Hematology Care Inc Cincinnati Ohio
United States Hema Onc Conslts-Grant Ave Columbus Ohio
United States Hematology Onc Consultants Columbus Ohio
United States The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. Columbus Ohio
United States Northwest Oncology/ Hematology Assoc. Coral Springs Florida
United States Wilshire Oncology Medical Group Corona California
United States Cons in Med Onc and Hem Darby Pennsylvania
United States UM Sylvester Deerfield Beach; Sylvester Cancer Ctr Deerfield Beach Florida
United States Gabrail Cancer Center Dover Ohio
United States Consultants in Medical Oncology/Hematology Drexel Hill Pennsylvania
United States Duke University Medical Center Durham North Carolina
United States Southdale Cancer Clinic U of M Medical Center, Fairview- Edina Edina Minnesota
United States Elmhurst Hospital Elmhurst Illinois
United States Florida Cancer Specialists - Englewood Englewood Florida
United States San Juan Oncology Associates Farmington New Mexico
United States Florida Cancer Specialists - Broadway Fort Myers Florida
United States Florida Cancer Specialists - Fort Myers (New Hampshire Ct) Fort Myers Florida
United States Florida Cancer Specialists-Broadway, Fort Myers Fort Myers Florida
United States Florida Cancer Specialists; SCRI Fort Myers Florida
United States Compassionate Cancer Care Fountain Valley California
United States Pacific Coast Hematology/Oncology Medical Group Fountain Valley California
United States St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr Fullerton California
United States Northeast Georgia Medical Center; Oncology Research Dept-5C Gainesville Georgia
United States Private Practice Robert R. Carroll, Md, Pa Gainesville Florida
United States Geneva-Interlakes Foundation Geneva New York
United States Wilshire Onc Med Grp., Inc Glendora California
United States Cancer & Hematology Center of West Michigan Grand Rapids Michigan
United States Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan
United States Hematology Oncology Consultants (NWK) Granville Ohio
United States Carolina Oncology Specialists, PA - Hickory Hickory North Carolina
United States Monroe Medical Associates - Hobart Hobart Indiana
United States St. Mary Medical Center Hobart Indiana
United States Memorial Cancer Institute Hollywood Florida
United States Memorial Regional Hospital Hollywood Florida
United States Memorial City-Main Office Houston Texas
United States Oncology Consultants Houston Texas
United States Park Plaza Houston Texas
United States Southwest Houston Texas
United States St. Joseph's Houston Texas
United States St. Luke's Houston Texas
United States Willowbrook Houston Texas
United States Carolina BioOncology Institute, PLCC Huntersville North Carolina
United States Hematology-Oncology of Indiana, Pc Indianapolis Indiana
United States Uni of Iowa Hospital&Clinic; Holden Comprehens. Cancer Ctr Iowa City Iowa
United States McLeod Cancer and Blood Center Johnson City Tennessee
United States NEA Baptist Clinic Jonesboro Arkansas
United States Katy-Christus St. Catherine Katy Texas
United States Armstrong County Memorial Hospital Kittanning Pennsylvania
United States University of Tennessee Cancer Institute;Hem-Onc Consultants Knoxville Tennessee
United States Wilshire Oncology Medical Group La Verne California
United States Cancer Center of Acadiana at Lafayette General Lafayette Louisiana
United States ProHEALTH Care Associates LLP Lake Success New York
United States Lakeland Regional Cancer Center Lakeland Florida
United States Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States NW Carolina Onc & Hem Lenoir North Carolina
United States Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology Lincoln Nebraska
United States St. Barnabas Cancer Center Livingston New Jersey
United States Cedars- Sinai Medical Center Los Angeles California
United States LAC USC Medical Center Los Angeles California
United States Ronald Reagan UCLA Medical Center Clin Lab Los Angeles California
United States TORI Central Administration Los Angeles California
United States UCLA Los Angeles California
United States UCLA Hematology / Oncology Clinic Los Angeles California
United States UCLA Med Ctr; Pharma Svcs Los Angeles California
United States Jewish Cancer Care Louisville Kentucky
United States Central Georgia Hematology Oncology Associates Macon Georgia
United States Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital Marietta Georgia
United States Jackson Memorial Hospital Miami Florida
United States University of Miami School of Medicine Miami Florida
United States Minneapolis Oncology Hamatology PA Minneapolis Minnesota
United States US Oncology Research at Minnesota Oncology Minneapolis Minnesota
United States Sutter Gould Medical Foundation; Clinical Research Modesto California
United States Oncology and Hematology Specialists Mountain Lakes New Jersey
United States Community Hospital; Pharmacy Munster Indiana
United States Monroe Medical Associates Munster Indiana
United States Northwest Oncology Munster Indiana
United States Hematology Oncology Consultants Ltd Naperville Illinois
United States Florida Cancer Specialists - Goodlette, Naples Naples Florida
United States Florida Cancer Specialists - Pine Ridge, Naples Naples Florida
United States Sarah Cannon Cancer Center - Tennessee Oncology, Pllc Nashville Tennessee
United States The Jones Clinic, PC New Albany Mississippi
United States Beth Israel Comprehensive Cancer Center Pharmacy New York New York
United States The Women'sOncology & Wellness Practice New York New York
United States Conslts in Med Onc (Newtown); Bryn Mawr Health Canc Ctr Newtown Square Pennsylvania
United States Norfolk Oncology Consultants Norfolk Nebraska
United States Kaiser Permanente - Oakland Oakland California
United States Northern Utah Associates Ogden Utah
United States Mercy Physicians of Oklahoma Oklahoma City Oklahoma
United States Hematology-Oncology Consultants, Pc Omaha Nebraska
United States Private Practice Orlando Florida
United States Ventura County Hematology-Oncology Specialists Oxnard California
United States UCLA Healthcare/Pasadena Oncology Pasadena California
United States Wilshire Oncology Medical Group Pasadena California
United States Breast Cancer Centre at Memorial Hospital West Pembroke Pines Florida
United States Uni of Pittsburgh; Magee-Women'S Hospital Pittsburgh Pennsylvania
United States Berkshire Hematology, Oncology Pc Pittsfield Massachusetts
United States Bay Area Cancer Research Group, LLC Pleasant Hill California
United States Wilshire Oncology Medical Group Pomona California
United States Florida Cancer Specialists - Port Charlotte Port Charlotte Florida
United States Quincy Medical Group Quincy Illinois
United States Wilshire Oncology Medical Group Rancho Cucamonga California
United States Consultants Med Onc & Hem Ridley Park Pennsylvania
United States Upstate Ny Cancer Research & Education Foundation Rochester New York
United States Community Cancer Center Rutland Regional Medical Center Rutland Vermont
United States UC Davis Cancer Center; Oncology Sacramento California
United States Oncology Care Associates PLLC Saint Joseph Michigan
United States South Texas Oncology Hematology San Antonio Texas
United States Kaiser Permanente San Diego; Hepatology Research San Diego California
United States K. Permanente - San Fransisco San Francisco California
United States K. Permanente - San Jose San Jose California
United States Sansum Santa Barbara Medical Foundation Clinic Santa Barbara California
United States Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara California
United States UCLA Hematology/Oncology Santa Monica California
United States Florida Cancer Specialists; Sarasota Sarasota Florida
United States HonorHealth Research Institute - Bisgrove Scottsdale Arizona
United States Christus Schumpert Health System Shreveport Louisiana
United States Oncology Consultants - Sugar Land Sugar Land Texas
United States Northwest Medical Specialties Tacoma Washington
United States Bay Area Oncology Tampa Florida
United States Medical College of Ohio; Cancer Institute Toledo Ohio
United States CA Care Associates-OK Oncology and Hematology Tulsa Oklahoma
United States Cancer Care Assoc-S. Ingo Tulsa Oklahoma
United States OK Oncology & Hematology PC Tulsa Oklahoma
United States UCLA / Santa Clarita Valley Cancer Center Valencia California
United States Kaiser Permanente - Vallejo Vallejo California
United States Florida Cancer Specialists - Sunset Lake, Venice Venice Florida
United States Florida Cancer Specialists - Venice (S. Tamiami Tr) Venice Florida
United States Family Medicine Vincennes Vincennes Indiana
United States St. Mary Medical Center Walla Walla Washington
United States K. Permanente - Walnut Creek Walnut Creek California
United States Central GA Cancer Care Warner Robins Georgia
United States Georgetown University Medical Center Lombardi Cancer Center Washington District of Columbia
United States MedStar Washington Hosp Center Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States Wilshire Oncology Medical Group West Covina California
United States Cleveland Clinic Florida Weston Florida
United States University of Kansas; Medical Center & Medical pavilion Westwood Kansas
United States Innovative clinical research institute/American institute of research Whittier California
United States Cancer Center of Kansas Wichita Kansas
United States Midwestern Regional Medical Center; Office of Research Zion Illinois

Sponsors (2)

Lead Sponsor Collaborator
Genentech, Inc. Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  China,  Costa Rica,  Croatia,  Ecuador,  Finland,  France,  Germany,  Guatemala,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  North Macedonia,  Philippines,  Poland,  Russian Federation,  Singapore,  Spain,  Thailand,  United Kingdom, 

References & Publications (1)

Baselga J, Cortés 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 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Survival Overall survival (OS) was the time from randomization to death from any cause, using Kaplan-Meier methodology. Survival data was collected every 18 weeks during the post-treatment follow-up period until death, loss to follow-up, or withdrawal of consent. Those who were alive, lost to follow up, or withdrew consent were censored at the latest date they participated in the study; those without post-baseline data were censored at 1 day. OS analyses were planned to take place at the primary completion date (First Interim), after 385 deaths (Event-Driven Final), and at the end of study (End-of-Study). A second interim OS analysis was planned due to a formal request from the European Medicines Agency. Median [range] time in weeks on study at each OS analysis (Pertuzumab vs. Placebo): First: 77.1 [0.7-165.3] vs. 73.1 [0.4-165.3]; Second: 117.1 [0.7-207.9] vs. 105.9 [0.4-207.9]; Event-Driven Final: 189.9 [0.7-304.1] vs. 140.5 [0.4-301.6]; End-of-Study: 201.8 [0.7-520.0] vs. 138.0 [0.4-514.7]. 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)
Secondary Progression-Free Survival (PFS) Determined by the Investigator PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by the investigator 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 PD or who had not died within 18 weeks of their last investigator-determined, progression-free tumor assessment were censored at the date of the last investigator 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 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)
Secondary Objective Response Determined by an Independent Review Facility An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by an independent review facility (IRF) using RECIST v1.0 on two consecutive occasions =4 weeks apart. For target lesions, CR: disappearance of all target lesions; PR: =30% decrease in the sum of the longest diameter (LD) of target lesions (baseline sum LD as reference); PD: =20% increase in the sum of the LD of target lesions (smallest sum of the LD recorded as reference) or appearance of =1 new lesion; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for PD. For non-target lesions, CR: disappearance of all non-target lesions; Incomplete/SD: persistence of =1 non-target lesions; PD: unequivocal progression of existing non-target lesions. 95% confidence intervals (CI) were calculated only for clinical responses using the Pearson-Clopper method. 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)
Secondary Duration of Objective Response Determined by an Independent Review Facility Duration of objective response (estimated using the Kaplan-Meier method) was defined as the time from the initial confirmed complete response (CR) or partial response (PR), the date of tumor assessment at which the CR/PR was first detected by the independent review facility (IRF) using RECIST version 1.0, until the date of IRF-determined progressive disease (PD), death from any cause within 18 weeks of the last tumor assessment, or first administration of next line of anti-cancer therapy (whichever occurred first). If the visit when the initial CR or PR was observed spanned multiple dates, the latest date was used. Only participants in the ITT analysis population with an IRF-determined objective response (CR or PR), observed prior to IRF-assessed PD, death or next line of anti-cancer therapy, were included in the analysis. Participants who did not progress or die after they had a confirmed response were censored at the date of their last IRF-evaluable tumor measurement. 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)
Secondary Time to Symptom Progression Time to symptom progression was defined as the time from randomization to the first symptom progression as measured by the Functional Assessment of Cancer Therapy-for patients with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contains 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer patients (breast cancer subscale [BCS]). All items in the questionnaire were rated by the patient on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96. A higher score indicates better perceived quality of life. A positive change score from baseline indicates improvement. Symptom progression was defined as a decrease from baseline of 5 points or more. Every 9 weeks from Baseline until investigator-determined progressive disease, up to the primary completion date (up to 3 years, 3 months)
Secondary Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events, by Most Severe Intensity (According to NCI-CTCAE v3.0) During the Treatment Period Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of the same AE in one participant. AEs reported prior to first crossover treatment were included in the Placebo arm, and in the Crossover arm after that date, for participants who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
Secondary Overall Number of Adverse Events by Severity (NCI-CTCAE v3.0 All Grades and Grades 3 to 5) Per 100 Patient-Years of Exposure During the Treatment Period Adverse event (AE) severity, including serious and non-serious AEs, was assessed according to the NCI-CTCAE version 3.0; if the AE was not specifically listed, the following grades of severity were used: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening or disabling; and Grade 5 is death. Multiple occurrences of the same AE in 1 participant were counted multiple times. Only AEs that started during the overall study treatment period were included. The cutoff date for inclusion of events and for calculation of patient-years was the date of the most recent follow-up of the participant, defined as the last available date during the treatment period, excluding pre-treatment and safety follow-up data. Confidence intervals were calculated assuming the number of events followed a Poisson distribution. Data reported prior to the date of first crossover treatment were included under the Placebo arm for participants who crossed over from placebo to pertuzumab. From Baseline to 42 days after the last dose of study treatment (total patient-years of exposure on study treatment in Placebo vs. Pertuzumab arms: 526.81 vs. 989.88 patient-years)
Secondary Cardiac-Related AEs to Monitor: Number of Participants Who Experienced at Least One Symptomatic Left Ventricular Dysfunction (LVD), Any LVD, or Serious AE Suggestive of Congestive Heart Failure by Severity During the Treatment Period Cardiac-related adverse events (AEs) to monitor during the study included investigator-assessed symptomatic left ventricular dysfunction (LVD), any LVD, or a serious adverse event (SAE) suggestive of congestive heart failure (CHF). All cardiac-related AEs were graded for severity according to NCI-CTCAE v3.0. Asymptomatic (Grades 1-2) and symptomatic (Grades 3-5) left ventricular systolic dysfunction (LVSD) both coded to the MedDRA preferred term LVD. Investigator-assessed events of symptomatic LVD were also graded for severity of symptoms according to Classes I (least severe) to IV (most severe) of the New York Heart Association (NYHA) Classification. SAEs suggestive of CHF were identified as serious events from the Standardized MedDRA Query (SMQ) (Wide) 'Cardiac Failure'. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
Secondary Number of Participants Who Experienced at Least One Adverse Event to Monitor (Excluding Cardiac-Related AEs) by Severity During the Treatment Period The clinical diagnoses listed in this table, excluding cardiac safety (summarized separately), were also selected as adverse events (AEs) to monitor based on clinical and nonclinical data for pertuzumab and the safety profile established for trastuzumab, monoclonal antibodies in general, and potential effects associated with HER receptor inhibition. Search strategies were defined by single or aggregate MedDRA Preferred Terms (PT) through Standardized MedDRA Queries (SMQ), where possible, or based on Roche AE Group Terms (AEGT). Diarrhoea AEs: High-Level Term (HLT) 'Diarrhoea (excl. infective)' and PT 'Diarrhoea infectious'. Leukopenic and Febrile Neutropenic Infections: AEs from 'Infections & Infestations' with start =14 days after start date of Grade =3 AEs in SMQ(narrow) 'Leukopenia' or PT 'Febrile neutropenia', respectively. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
Secondary Overall Number of Participants Who Experienced at Least One Adverse Event Leading to Discontinuation of Any or All Study Medication Participants could continue study treatment with pertuzumab/placebo plus trastuzumab when docetaxel was discontinued due to an adverse event (AE). Discontinuation of pertuzumab/placebo or trastuzumab due to an AE led to discontinuation of all study medication. The number of participants who discontinued any study medication due to an AE includes those who discontinued all study medication and those who discontinued docetaxel only and then continued on targeted therapy (note: some of these participants may have subsequently discontinued all treatment due to a separate AE). Multiple occurrences of the same adverse event in 1 participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for those who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
Secondary Overall Number of Participants Who Experienced at Least One Adverse Event That Resulted in Interruption or Modification of Any Study Medication Pertuzumab, trastuzumab, and docetaxel administration could have been delayed to assess or treat adverse events (AEs). Docetaxel dose reduction was allowed for myelosuppression, hepatic dysfunction, and other toxicities. No dose reduction was allowed for pertuzumab or trastuzumab. Multiple occurrences of the same adverse event in one participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
Secondary Number of Participants Who Experienced at Least One Adverse Event During the Post-Treatment Follow-Up Period The post-treatment period was defined as the period following the treatment discontinuation visit. Only the following new adverse events (AEs) should have been reported during the post-treatment follow-up period: 1. Cardiac events (regardless of causality or seriousness) that started up to 1 year after the last dose, except for symptomatic left ventricular systolic dysfunction (regardless of causality) that started up to 3 years after the last dose; and 2. Treatment-related serious AEs, regardless of start date. AEs are listed by Medical Dictionary for Regulatory Activities, Version 21.1 (MedDRA v21.1) System Organ Class (SOC) and Preferred Term (PT); PTs fall under the SOC that is listed immediately above it in the table. Multiple occurrences of the same AE in one participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab. From Day 43 after discontinuation of all study medication to end of post-treatment follow-up period (up to 3 years)
Secondary Number of Participants by Categories for the Maximum Absolute Decrease From Baseline in LVEF Value During the Treatment Period All participants were required to have an left ventricular ejection fraction (LVEF) =50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Data reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (see Description for time on study treatment per arm)
Secondary Baseline LVEF Value and Change in LVEF From Baseline at Maximum Absolute Decrease Value During the Treatment Period All participants were required to have a left ventricular ejection fraction (LVEF) =50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Only data reported prior to the date of first crossover treatment were included for participants who crossed over from placebo to pertuzumab. Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks)
Secondary Number of Participants With Laboratory Abnormalities in Blood Biochemistry Tests by Highest Grade According to NCI-CTCAE v3.0 During the Treatment Period Clinical laboratory tests for blood biochemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest grade according to NCI-CTCAE v3.0. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. ALP = alkaline phosphatase; GGT = gamma-glutamyl transferase; SGOT = serum glutamic-oxaloacetic transaminase; SGPT = serum glutamic-pyruvic transaminase On Day 1 of every treatment cycle (1 cycle is 21 days) until Treatment Discontinuation Visit (see Description for time on study treatment per arm)
Secondary Number of Participants With Laboratory Abnormalities in Hematology Tests by Highest Grade According to NCI-CTCAE v3.0 During the Treatment Period Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest grade according to NCI-CTCAE v3.0. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. INR = International Normalized Ratio; PTT = partial thromboplastin time; WBC = white blood cell On Day 1 (and Day 8 for some measures) of every treatment cycle (1 cycle is 21 days) until Treatment Discontinuation Visit (see Description for time on study treatment per arm)
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