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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

Tracking Information
First Submitted Date November 5, 2019
First Posted Date November 8, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date December 4, 2019
Estimated Primary Completion Date November 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2019)
Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America [ Time Frame: Baseline up to 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 6, 2019)
  • Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0) [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Locoregional Recurrence (LRR) [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Event Free Survival (EFS) [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Invasive Disease-Free Survival (iDFS) [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Overall Survival [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Anti-Cancer Treatment Modifications [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants (During Observation Period) with Pregnancy [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants (during Observation Period) with Pregnancy Outcomes [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Non-Serious Adverse Events of Special Interests [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with AEs Leading to Discontinuation or Dose Modification [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants with Cardiac Safety Events [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens [ Time Frame: Baseline up to approximately 6 years ]
  • Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods [ Time Frame: Baseline up to approximately 6 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.)
Condition Breast Cancer
Intervention
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 6, 2019)
4500
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 28, 2025
Estimated Primary Completion Date November 28, 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Argentina,   Brazil,   Chile,   Mexico,   Uruguay
Removed Location Countries  
 
Administrative Information
NCT Number NCT04158258
Other Study ID Numbers MO39485
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Latin American Cooperative Oncology Group
Investigators Not Provided
PRS Account Hoffmann-La Roche
Verification Date November 2019