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A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

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ClinicalTrials.gov Identifier: NCT04158258
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Latin American Cooperative Oncology Group
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Bevacizumab Drug: Trastuzumab Drug: Ado-trastuzumab emtamsine Drug: Pertuzumab Drug: Atezolizumab Drug: Capecitabine

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Study Type : Observational
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA
Estimated Study Start Date : December 4, 2019
Estimated Primary Completion Date : November 28, 2025
Estimated Study Completion Date : November 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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.
Drug: 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.
Other Name: Avastin

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.
Drug: 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.
Other Name: Herceptin

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.
Drug: 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.
Other Name: Kadcyla

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.
Drug: 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.
Other Name: Perjeta

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.
Drug: 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.
Other Name: Tecentriq

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.
Drug: 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.




Primary Outcome Measures :
  1. Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America [ Time Frame: Baseline up to 12 months ]

Secondary Outcome Measures :
  1. Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0) [ Time Frame: Baseline up to approximately 6 years ]
  2. Percentage of Participants with Locoregional Recurrence (LRR) [ Time Frame: Baseline up to approximately 6 years ]
  3. Percentage of Participants with Event Free Survival (EFS) [ Time Frame: Baseline up to approximately 6 years ]
  4. Percentage of Participants with Invasive Disease-Free Survival (iDFS) [ Time Frame: Baseline up to approximately 6 years ]
  5. Percentage of Participants with Overall Survival [ Time Frame: Baseline up to approximately 6 years ]
  6. Percentage of Participants with Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 6 years ]
  7. Percentage of Participants with Anti-Cancer Treatment Modifications [ Time Frame: Baseline up to approximately 6 years ]
  8. Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics [ Time Frame: Baseline up to approximately 6 years ]
  9. Percentage of Participants (During Observation Period) with Pregnancy [ Time Frame: Baseline up to approximately 6 years ]
  10. Percentage of Participants (during Observation Period) with Pregnancy Outcomes [ Time Frame: Baseline up to approximately 6 years ]
  11. Percentage of Participants with Non-Serious Adverse Events of Special Interests [ Time Frame: Baseline up to approximately 6 years ]
  12. Percentage of Participants with AEs Leading to Discontinuation or Dose Modification [ Time Frame: Baseline up to approximately 6 years ]
  13. Percentage of Participants with Cardiac Safety Events [ Time Frame: Baseline up to approximately 6 years ]
  14. Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens [ Time Frame: Baseline up to approximately 6 years ]
  15. Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods [ Time Frame: Baseline up to approximately 6 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158258


Locations
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Argentina
Instituto Alexander Fleming Not yet recruiting
Buenos Aires, Argentina, 1426
Consultorio Privado Vidal Not yet recruiting
Buenos Aires, Argentina, B1708EIL
Instituto Oncologico De Cordoba; Oncology Not yet recruiting
Cordoba, Argentina, 5000
Hospital Privado Centro Medico de Cordoba Not yet recruiting
Córdoba, Argentina, 5016
Instituto de Oncología de Rosario Not yet recruiting
Rosario, Argentina, S2000KZE
Sanatorio de la Mujer Not yet recruiting
Rosario, Argentina, S2000ORE
Brazil
Crio - Centro Regional Integrado de Oncologia Not yet recruiting
Fortaleza, CE, Brazil, 60336-550
Hospital do Câncer de Londrina Not yet recruiting
Londrina, PR, Brazil, 86015-520
Instituto Nacional de Cancer - INCa; Oncologia Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Inst. de Vita Not yet recruiting
Caxias do Sul, RS, Brazil, 95020-450
Hospital Moinhos de Vento Not yet recruiting
Porto Alegre, RS, Brazil, 90035-001
Centro de Pesquisa em Oncologia Not yet recruiting
Porto Alegre, RS, Brazil, 90840-440
Centro de Pesquisas Oncologicas - CEPON Not yet recruiting
Florianopolis, SC, Brazil, 88034-000
Hospital A. C. Camargo Not yet recruiting
Sao Paulo, SP, Brazil, 01509-010
Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia Not yet recruiting
São Paulo, SP, Brazil, 03102-002
Chile
Hospital Regional de Temuco y Villarrica Not yet recruiting
Región De La Araucanía, Chile
Clinica Las Condes Not yet recruiting
Santiago, Chile, 7591046
Instituto Nacional del Cancer Not yet recruiting
Santiago, Chile, 8380000
Mexico
Instituto Nacional de Cancerologia Not yet recruiting
Mexico City, Mexico, 14080
Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey Not yet recruiting
Monterrey, Mexico, 64710
Centro Oncologico Estatal ISSEMYM Not yet recruiting
Toluca, Mexico, 50180
Uruguay
Hospital Pereira Rossell; Oncology Department Not yet recruiting
Montevideo, Uruguay, 11600
Sanatorio CASMU; Oncología Not yet recruiting
Montevideo, Uruguay
Sponsors and Collaborators
Hoffmann-La Roche
Latin American Cooperative Oncology Group

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04158258     History of Changes
Other Study ID Numbers: MO39485
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Trastuzumab
Pertuzumab
Capecitabine
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action