General information Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
A study to observe patients characteristics, treatment patterns and outcomes in patients with newly diagnosed breast cancer in Latin America.
Acronym of Scientific Title:
Secondary indentifying numbers:
MO39485
NCT04158258
#0615
Issuing authority of the secondary identifying numbers:
Roche Servicios S.A.
ClinicalTrials.gov
Latin American Cooperative Oncology Group (LACOG)
Source(s) of monetary or material support:
Primary Sponsor - Roche Servicios S.A.
Authorization for beginning Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
Medical Specialty :
Medical Doctor, Second degree specialist in oncology
Affiliation:
"Hermanos Ameijeiras" Surgical-Clinic hospital (HHA)
Postal address:
San Lazaro No. 701 corner to Belascoain.
Clinical sites to participate Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Argentina
Brazil
Chile
Colombia
Costa Rica
Dominican Republic
Ecuador
Guatemala
Mexico
Peru
Uruguay
Clinical sites:
Sites in the Latin America countries that participate in the study
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
Health condition and Intervention Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Newly Diagnosed Breast Cancer
Health condition(s) code:
Breast Neoplasms
Breast Diseases
Skin Diseases
Skin and Connective Tissue Diseases
Intervention(s):
Group 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
Group 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
Group 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
Group 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
Group 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
Group 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 code:
Bevacizumab
Trastuzumab
Ado-Trastuzumab Emtansine
Capecitabine
Intervention keyword:
Avastin
Herceptin
Kadcyla
Pertuzumab
Perjeta
Atezolizumab
Tecentriq
Outcomes and Timepoint Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Percentage of participants with different subtypes of breast cancer at the time of diagnosis in Latin America. Measurement time: baseline up to 12 months
Key secondary outcomes:
1. Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0). Measurement time: Baseline up to approximately 6 years.
2. Percentage of Participants with Locoregional Recurrence (LRR). Measurement time: Baseline up to approximately 6 years.
3. Percentage of Participants with Event Free Survival (EFS). Measurement time: Baseline up to approximately 6 years.
4. Percentage of Participants with Invasive Disease-Free Survival (iDFS). Measurement time: Baseline up to approximately 6 years.
5. Percentage of Participants with Overall Survival. Measurement time: Baseline up to approximately 6 years.
6. Percentage of Participants with Objective Response Rate (ORR). Measurement time: Baseline up to approximately 6 years.
7. Percentage of Participants with Anti-Cancer Treatment Modifications. Measurement time: Baseline up to approximately 6 years.
8. Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics. Measurement time: Baseline up to approximately 6 years.
9. Percentage of Participants (During Observation Period) with Pregnancy. Measurement time: Baseline up to approximately 6 years.
10. Percentage of Participants (during Observation Period) with Pregnancy Outcomes. Measurement time: Baseline up to approximately 6 years.
11. Percentage of Participants with Non-Serious Adverse Events of Special Interests. Measurement time: Baseline up to approximately 6 years.
12. Percentage of Participants with AEs Leading to Discontinuation or Dose Modification. Measurement time: Baseline up to approximately 6 years.
13. Percentage of Participants with Cardiac Safety Events. Measurement time: Baseline up to approximately 6 years.
14. Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens. Measurement time: Baseline up to approximately 6 years.
15. Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods. Measurement time: Baseline up to approximately 6 years.
Selection criterias Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
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:
1. 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
2. Patients not receiving the Roche studied medicinal product, but a biosimilar
Study design Section to complete information about the characteristics of the study design.
Other purpose:
Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer
Target sample size:
4500 overall, 288 in Cuba
Contact for public queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
Postal Address:
Ultrapark Free Zone, Building 4.
Contact for scientific queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
Data Sharing Section to complete the data related to the data sharing plan.
Research Ethics Committees Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
"Hermanos Ameijeiras" Clinical Surgical Hospital (HHA)
Status of evaluation date of Ethic Committee:
Postal address of Ethic Committee :
San Lazaro street # 701 esq. a Belascoain, Centro Habana, Havana, C.P:10400, Cuba
About study completion Section to complete the data related to the study completion.
Registration and Update Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
