Breast CancerNCT04158258
A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
An observational study of Breast Cancer, run by Hoffmann-La Roche at 30 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab, Trastuzumab and Ado-trastuzumab emtamsine
- How many people
- 2,907 participants
- Where
- 30 sitesin 10 countries
- Study dates
- 21 Feb 2020to 31 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 10 countries.
30 sites in 10 countries
Brazil7 sites
Inst. de Vita
Caxias do Sul, Rio Grande do Sul, 95020-450
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550
Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520
Centro de Pesquisa em Oncologia
Porto Alegre, Rio Grande do Sul, 90840-440
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120
Instituto Brasileiro De Controle Do Câncer - IBCC
São Paulo, 03102-002
Hospital Jardim Amália
Volta Redonda, Rio de Janeiro, 27251-260
Argentina6 sites
Instituto Alexander Fleming
Buenos Aires, 1426
Instituto Oncologico De Cordoba
Córdoba, 5000
Hospital Privado Centro Medico de Cordoba
Córdoba, 5016
Hospital de Morón
Morón
Instituto de Oncología de Rosario
Rosario, S2000KZE
Sanatorio de la Mujer
Rosario, S2000ORE
Colombia4 sites
Organización Clínica Bonnadona Prevenir S.A.S
Barranquilla
Inst. Nacional de Cancerologia
Bogotá
Centro Medico Imbanaco
Cali
Fundacion Cardiovascular de Colombia - Instituto del Corazón
Floridablanca
Chile3 sites
Clinica Las Condes
Santiago, 7591046
Instituto Nacional del Cancer
Santiago, 8380000
Hospital Dr. Hernan Henriquez Aravena
Temuco, 4781151
Mexico3 sites
Instituto Nacional de Cancerologia
Mexico City, Mexico CITY (federal District), 14080
Hospital Zambrano Hellion TecSalud
Monterrey, Nuevo León
Centro Oncologico Estatal ISSEMYM
Toluca, 50180
Peru3 sites
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038
Clinica Internacional, Sede San Borja
Lima, Lima 41
Aliada Centro Oncologico
Lima
Dominican Republic1 site
Instituto de Oncologia Dr. Heriberto Pieter
Santo Domingo, 10150
About this study
Official title: A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA
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.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Trastuzumab, Ado-trastuzumab emtamsine, Pertuzumab, Atezolizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
TrastuzumabDrug
Also called Herceptin
Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
Ado-trastuzumab emtamsineDrug
Also called Kadcyla
Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
PertuzumabDrug
Also called Perjeta
Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
AtezolizumabDrug
Also called Tecentriq
Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
CapecitabineDrug
Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling. Receives: Drug: Bevacizumab | |
| Trastuzumab | Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling. Receives: Drug: Trastuzumab | |
| Ado-trastuzumab emtamsine | Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling. Receives: Drug: Ado-trastuzumab emtamsine | |
| Pertuzumab | Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling. Receives: Drug: Pertuzumab | |
| Atezolizumab | Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling. Receives: Drug: Atezolizumab | |
| Capecitabine | Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America
Measured: Baseline up to 12 months
Secondary outcomes (15)
Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)
Measured: Baseline up to approximately 6 years
Percentage of Participants with Locoregional Recurrence (LRR)
Measured: Baseline up to approximately 6 years
Percentage of Participants with Event Free Survival (EFS)
Measured: Baseline up to approximately 6 years
Percentage of Participants with Invasive Disease-Free Survival (iDFS)
Measured: Baseline up to approximately 6 years
Percentage of Participants with Overall Survival
Measured: Baseline up to approximately 6 years
Percentage of Participants with Objective Response Rate (ORR)
Measured: Baseline up to approximately 6 years
Percentage of Participants with Anti-Cancer Treatment Modifications
Measured: Baseline up to approximately 6 years
Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics
Measured: Baseline up to approximately 6 years
Percentage of Participants (During Observation Period) with Pregnancy
Measured: Baseline up to approximately 6 years
Percentage of Participants (during Observation Period) with Pregnancy Outcomes
Measured: Baseline up to approximately 6 years
Percentage of Participants with Non-Serious Adverse Events of Special Interests
Measured: Baseline up to approximately 6 years
Percentage of Participants with AEs Leading to Discontinuation or Dose Modification
Measured: Baseline up to approximately 6 years
Percentage of Participants with Cardiac Safety Events
Measured: Baseline up to approximately 6 years
Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens
Measured: Baseline up to approximately 6 years
Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods
Measured: Baseline up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start21 Feb 2020
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Latin American Cooperative Oncology Group
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158258
- Sponsor's protocol ID
- MO39485
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2019
- Last updated
- 17 Aug 2026
- Results posted
- No
- Individual data sharing
- No