Clinical trial NCT04158258: A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
Official title: A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Latin American Cooperative Oncology Group
First posted: 2019-11-08
Enrollment: 2907
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be recruited from approximately 10 countries and from a variety of healthcare sites (ex: specialty care, private practice, teaching institution, etc.)

Brief summary: A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed newly diagnosed stage I to IV (recurrent or de novo) breast cancer no more than 12 months prior to site activation, although they can have received anti-cancer treatment during that time

Exclusion Criteria:

* Patients not receiving treatment for breast cancer with national approved drugs according to standard of care and in line with the current summary of product characteristics (SPC) /local labeling
* Patients not receiving the Roche studied medicinal product, but a biosimilar

Primary outcomes:
measure: Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Locoregional Recurrence (LRR)
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Event Free Survival (EFS)
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Invasive Disease-Free Survival (iDFS)
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Overall Survival
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Objective Response Rate (ORR)
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Anti-Cancer Treatment Modifications
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants (During Observation Period) with Pregnancy
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants (during Observation Period) with Pregnancy Outcomes
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Non-Serious Adverse Events of Special Interests
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with AEs Leading to Discontinuation or Dose Modification
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants with Cardiac Safety Events
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens
timeFrame: Baseline up to approximately 6 years
measure: Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods
timeFrame: Baseline up to approximately 6 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Cordoba
country: Argentina
facility: Instituto Oncologico De Cordoba
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Moron
country: Argentina
facility: Hospital de Morón
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Rosario
country: Argentina
facility: Sanatorio de la Mujer
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: Ceará
city: Londrina
country: Brazil
facility: Hospital do Câncer de Londrina
state: Paraná
city: Volta Redonda
country: Brazil
facility: Hospital Jardim Amália
state: Rio De Janeiro
city: Caxias do Sul
country: Brazil
facility: Inst. de Vita
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa
city: São Paulo
country: Brazil
facility: Instituto Brasileiro De Controle Do Câncer - IBCC
city: Santiago
country: Chile
facility: Clinica Las Condes
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer
city: Temuco
country: Chile
facility: Hospital Dr. Hernan Henriquez Aravena
city: Barranquilla
country: Colombia
facility: Organización Clínica Bonnadona Prevenir S.A.S
city: Bogota
country: Colombia
facility: Inst. Nacional de Cancerologia
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia - Instituto del Corazón
city: La Habana
country: Cuba
facility: Hospital Hermanos Ameijeiras
city: Santo Domingo
country: Dominican Republic
facility: Instituto de Oncologia Dr. Heriberto Pieter
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Hospital Zambrano Hellion TecSalud
state: Nuevo LEON
city: Toluca
country: Mexico
facility: Centro Oncologico Estatal ISSEMYM
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja
city: Lima
country: Peru
facility: Aliada Centro Oncologico
city: Montevideo
country: Uruguay
facility: Sanatorio CASMU
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: