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

Study Overview
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Brief Summary
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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.

Official Title
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A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Trastuzumab
* Drug: Ado-trastuzumab emtamsine
* Drug: Pertuzumab
* Drug: Atezolizumab
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bevacizumab<br>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<br>* 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.<br>* Other names: Avastin;|
| Trastuzumab<br>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<br>* 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.<br>* Other names: Herceptin;|
| Ado-trastuzumab emtamsine<br>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<br>* 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.<br>* Other names: Kadcyla;|
| Pertuzumab<br>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<br>* 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.<br>* Other names: Perjeta;|
| Atezolizumab<br>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<br>* 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.<br>* Other names: Tecentriq;|
| Capecitabine<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America |  | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0) |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Locoregional Recurrence (LRR) |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Event Free Survival (EFS) |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Invasive Disease-Free Survival (iDFS) |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Overall Survival |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Objective Response Rate (ORR) |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Anti-Cancer Treatment Modifications |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics |  | Baseline up to approximately 6 years | 
| Percentage of Participants (During Observation Period) with Pregnancy |  | Baseline up to approximately 6 years | 
| Percentage of Participants (during Observation Period) with Pregnancy Outcomes |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Non-Serious Adverse Events of Special Interests |  | Baseline up to approximately 6 years | 
| Percentage of Participants with AEs Leading to Discontinuation or Dose Modification |  | Baseline up to approximately 6 years | 
| Percentage of Participants with Cardiac Safety Events |  | Baseline up to approximately 6 years | 
| Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens |  | Baseline up to approximately 6 years | 
| Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods |  | Baseline up to approximately 6 years |