Spots Global Cancer Trial Database for A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
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Trial Identification
Brief Title: A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
Official Title: A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer
Study ID: NCT01491737
Conditions
Study Description
Brief Summary: This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Ironwood Cancer TX & Rsch Ctrs, Chandler, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Comprehensive Blood & CA Ctr; Research, Bakersfield, California, United States
Rocky Mountain Cancer Center - Denver, Denver, Colorado, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Advanced Medical Specialties, Miami, Florida, United States
Georgia Cancer Specialists - Northside, Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta, Georgia, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Crescent City Rsrch Cnsrtm, LLC, Marrero, Louisiana, United States
Weinberg CA Inst Franklin Sq, Baltimore, Maryland, United States
Center For Cancer and Blood Disorders, Bethesda, Maryland, United States
Washington University School of Medicine; Internal Medicine - Renal, Saint Louis, Missouri, United States
Hematology Oncology Associates; Carol G. Simon Ctr, Morristown, New Jersey, United States
Cooper Hospital; Hematology & Oncology, Voorhees, New Jersey, United States
NS-Long Island Jewish Hlth Sys, Lake Success, New York, United States
ProHEALTH Care Associates LLP, Lake Success, New York, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Baylor College of Medicine; Lester & Sue Smith Breast Ctr, Houston, Texas, United States
Scott and White Hospital; Cancer Center, Temple, Texas, United States
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia, Sao Paulo, SP, Brazil
Hospital Sao Jose, São Paulo, SP, Brazil
HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France
Clinique Tivoli; Sce Radiotherapie, Bordeaux, , France
Hopital Morvan; Oncologie - Radiotherapie, Brest, , France
Centre Jean Perrin; Oncologie, Clermont Ferrand, , France
Clinique De La Sauvegarde; Chimiotherapie, Lyon, , France
Centre Catherine de Sienne; Chimiotherapie, Nantes, , France
Centre Antoine Lacassagne; Hopital De Jour A2, Nice, , France
CH De Senlis; Medecine 2, Senlis, , France
Clinique Pasteur; Oncologie Medicale, Toulouse, , France
Centre Alexis Vautrin; Oncologie Medicale, Vandoeuvre-les-nancy, , France
Indraprastha Apollo Hospitals, New Delhi, Delhi, India
Bangalore Institute of Oncology, Bangalore, Karnataka, India
Jaslok Hospital & Research Centre; Medical Oncology, Mumbai, Maharashtra, India
Apollo Speciality Hospital, Chennai, , India
Ruby Hall Clinic, Pune, , India
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica, Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna, Emilia-Romagna, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma, Emilia-Romagna, Italy
A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica, Pordenone, Friuli-Venezia Giulia, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia, Sora, Lazio, Italy
Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica, Castellanza, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
IRCCS Fondazione Maugeri; Oncologia Medica I, Pavia, Lombardia, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica, Bari, Puglia, Italy
Ospedale Antonio Perrino; Oncologia Medica, Brindisi, Puglia, Italy
Ospedale Vito Fazzi; Div. Oncoematologia, Lecce, Puglia, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica, Catania, Sicilia, Italy
A.O. Careggi; Radioterapia, Firenze, Toscana, Italy
Ospedale Misericordia E Dolce; Oncologia Medica, Prato, Toscana, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Hospital Provincial de Castellon; Servicio de Oncologia, Castellon de La Plana, Castellon, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia, San Sebastian, Guipuzcoa, Spain
Hospital de Donostia; Servicio de Oncologia Medica, San Sebastian, Guipuzcoa, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital de San Pedro de Alcantara, Caceres, , Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, La Coruña, , Spain
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia, La Coruña, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lerida, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Ankara, , Turkey
Ankara City Hospital, Ankara, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Brighton and Sussex Univ Hosp, Brighton, , United Kingdom
University Hospital coventry; Oncology Department, Coventry, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Queen Elizabeth Hospital, London, , United Kingdom
Queen Alexandra Hospital, Portsmouth, Portsmouth, , United Kingdom
Scarborough General Hospital, Scarborough, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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