Revisions for A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America | Registro Público Cubano de Ensayos Clínicos

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Revision of 18 August 2021 - 5:41pm:

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

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.

Acronym of Public Title:

LatinaBreast (MO39485)

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:

LatinaBreast

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)

Authorization date :

06/08/2020

Reference number:

RPCEC00000329

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Luis

Last name:

Soriano Garcia

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.

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761926

Email address:

onco@hha.sld.cu

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

Recruitment status:

Complete

Date of first enrollment:

23/07/2020

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.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Observational

Purpose:

Other

Other purpose:

Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

N/A

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

First Name:

Sofia

Last Name:

Chaves

Specialty:

Pharmacy

Affiliation:

Roche Servicios S.A

Postal Address:

Ultrapark Free Zone, Building 4.

City:

La Aurora de Heredia

Country:

Costa Rica

Zip Code:

3438-1000

Telephone:

+506 2298-1585

Email :

sofia.chaves@roche.com

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.

First Name:

Sofia

Last Name:

Chaves

Specialty:

Pharmacy

Affiliation:

Roche Servicios S.A

Postal Address:

Ultrapark, Building 4

City:

La Aurora de Heredia

Country:

Costa Rica

Zip Code:

3438-1000

Telephone:

+506 2298-1585

Email :

sofia.chaves@roche.com

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:

Approved

Status of evaluation date of Ethic Committee:

21/02/2020

Postal address of Ethic Committee :

San Lazaro street # 701 esq. a Belascoain, Centro Habana, Havana, C.P:10400, Cuba

Telephone:

+53-78761000

Email:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

2763 Globally and 25 in Cuba

Study completion date:

25/07/2025

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).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000329

Date of Registration in Primary Registry:

06/08/2020

Record Verification Date:

2021/07/22

Next update date:

2022/07/22

Link to the spanish version:

Click here

Registered Trials

Registration process

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

About the RPCEC

Useful resources