Spots Global Cancer Trial Database for A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
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Trial Identification
Brief Title: A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
Official Title: A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Patients With HER2-Positive Early Breast Cancer
Study ID: NCT03674112
Conditions
Study Description
Brief Summary: This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Cancer Center - Lakewood (West), Lakewood, Colorado, United States
Illinois Cancer Care, Peoria, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Maryland Oncology Hematology, Rockville, Maryland, United States
Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Memorial City, Houston, Texas, United States
USOR - Texas Oncology - San Antonio Northeast, San Antonio, Texas, United States
Texas Oncology- Northeast Texas, Tyler, Texas, United States
Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Câncer E Transplante, Curitiba, PR, Brazil
Clinicas Oncologicas Integradas - COI, Rio De Janeiro, RJ, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP, Sao Paulo, SP, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA, Sao Paulo, SP, Brazil
Bradford Hill Centro de Investigaciones Clinicas, Recoleta, , Chile
Hospital Hermanos Ameijeiras, La Habana, , Cuba
Instituto Nacional de Oncología y Radiología (INOR), La Habana, , Cuba
KYS Sadesairaala; Syopatautien poliklinikka, Kuopio, , Finland
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka, Vaasa, , Finland
Princess Margaret Hospital, Oncology; Department of Oncology, Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin, , Hong Kong
King Hussein Cancer Center, Amman, , Jordan
Bellevue Medical Center, El-Metn, , Lebanon
Hammoud Hospital, Saida, , Lebanon
Consultorio Privado (José Luis González Trujillo), Leon, Guanajuato, Mexico
Centro Médico Zambrano Hellion, Monterrey, Nuevo LEON, Mexico
Cuidados oncologicos, Querétaro, Queretaro, Mexico
Centro Oncológico de Panamá, Panama, , Panama
Centro Hemato Oncologico Panama, Panama, , Panama
Hospital da Luz; Departamento de Oncologia Medica, Lisboa, , Portugal
Hospital de Santa Maria; Servico de Oncologia Medica, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
National Center for Cancer Care and Research, Doha, , Qatar
King Fahad Medical City; Gastroentrology, Riyadh, , Saudi Arabia
Institute of Oncology and Radiology of Serbia, Belgrade, , Serbia
Clinical Centre Nis, Clinic for Oncology, Nis, , Serbia
Hospital General Universitario de Elche; Servicio de Oncologia, Elche, Alicante, Spain
Hospital Universitario de Canarias;servicio de Oncologia, La Laguna, Tenerife, Spain
Sodersjukhuset; Onkologkliniken, Stockholm, , Sweden
Västmanlands sjukhus Västerås, Onkologkliniken, Västerås, , Sweden
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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