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Brief Title: A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
Official Title: A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
Study ID: NCT05415215
Brief Summary: This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
University Clinical Center of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Cantonal Hospital Zenica; Department for Oncology, Zenica, , Bosnia and Herzegovina
Crio - Centro Regional Integrado de Oncologia, Fortaleza, CE, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology, Panagyurishte, , Bulgaria
DDODIU-Plovdiv, EOOD; Third Internal Department, Plovdiv, , Bulgaria
MHAT Nadezhda, Sofia, , Bulgaria
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
Centro de Estudios Clínicos SAGA, Santiago, , Chile
Clinica Vespucio, Santiago, , Chile
Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer, San Jose, , Costa Rica
Clinica CIMCA, San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas, San José, , Costa Rica
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
Saifee Hospital, Mumbai, Maharashtra, India
TATA Medical Centre; Medical Oncology, Kolkata, WEST Bengal, India
International Cancer Institute (ICI), Eldoret, , Kenya
Aga Khan University Hospital, Nairobi, , Kenya
Korea University Anam Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Iem-Fucam, D.f., Mexico CITY (federal District), Mexico
Oncologico Potosino, San Luis Potosí, SAN LUIS Potosi, Mexico
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica, Arequipa, , Peru
Oncocenter Peru S.A.C.; Oncosalud, Lima, , Peru
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Tan Tock Seng Hospital; Oncology, Singapore, , Singapore
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Wilgers Oncology Centre, Pretoria, , South Africa
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia, , Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia, Salamanca, , Spain
Gulhane Training and Research Hospital, Ankara, , Turkey
Ankara City Hospital; Oncology, Ankara, , Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne, , Turkey
Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology, Istanbul, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR