Spots Global Cancer Trial Database for A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
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Trial Identification
Brief Title: A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Official Title: A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer
Study ID: NCT02131064
Conditions
Study Description
Brief Summary: This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (\>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period. Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr, Fullerton, California, United States
Cancer Care Assoc Med Group, Los Angeles, California, United States
Coastal Integrative Cancer Care, San Luis Obispo, California, United States
Central Coast Medical Oncology, Santa Maria, California, United States
UCLA Hematology/Oncology, Santa Monica, California, United States
Memorial Cancer Institute, Hollywood, Florida, United States
Md Anderson Cancer Center Orlando, Orlando, Florida, United States
New England Cancer Specialists, Scarborough, Maine, United States
Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States
Montefiore Medical Center, Bronx, New York, United States
ProHEALTH Care Associates LLP, Lake Success, New York, United States
Hope A Women's Cancer Center, Asheville, North Carolina, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Roper Bon Secours St. Francis Cancer Center, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Clinique Saint-Joseph, Liège, , Belgium
Clinique Ste-Elisabeth, Pharmacie, Namur, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Cross Cancer Institute ; Dept of Medical Oncology, Edmonton, Alberta, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
St. Michael'S Hospital, Toronto, Ontario, Canada
Chum Hospital Notre Dame, Montreal, Quebec, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY, Quebec, , Canada
Ico - Paul Papin, Angers, , France
HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France
Hopital Morvan, Brest, , France
CHD Les Oudairies, La Roche Sur Yon, , France
Centre Oscar Lambret, Lille, , France
Institut Paoli Calmettes, Marseille, , France
Centre Catherine De Sienne, Nantes, , France
Centre Rene Gauducheau, Saint Herblain, , France
Nouvel Hopital Civil - CHU Strasbourg, Strasbourg, , France
Klinikum Sindelfingen-Böblingen; Frauenklinik, Böblingen, , Germany
Luisenkrankenhaus GmbH, Brustzentrum, Düsseldorf, , Germany
Universitätsklinikum Erlangen; Frauenklinik, Erlangen, , Germany
Universitätsklinikum Mainz, Mainz, , Germany
Interdisziplinäres Onkologisches Zentrum, München, , Germany
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
Regional Oncology Hospital Of Kursk; Chemotherapy, Kislino, Kursk Region, , Russian Federation
S.I. Russian Oncological Research Center n.a. N.N. Blokhin, Moscow, , Russian Federation
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis, Orenburg, , Russian Federation
Railway Clinical Hospital on Saratov - 2 Station Oao "Rzhd", Saratov, , Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary, St Petersburg, , Russian Federation
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia, San Sebastian, Guipuzcoa, Spain
Hospital Universitari de Lleida Arnau de Vilanova, Lleida, Lerida, Spain
Hospital Nuestra Señora de Sonsoles; servicio de Oncologia, Avila, , Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Fundacio Santa Creu I Sant Pau, Barcelona, , Spain
Complejo Hospitalario de Jaen, Jaen, , Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, La Coruña, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital Quiron de Madrid; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung, , Taiwan
National Taiwan Uni Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Mackay Memorial Hospital; Dept of Surgery, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Cherkassy Regional Oncological Hospital, Cherkassy, , Ukraine
State Medical Academy; Oncology, Dnipropetrovsk, , Ukraine
Karkiv Regional Oncology Center, Kharkiv, , Ukraine
Lvov State Regional Center, Lvov, , Ukraine
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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