PRECAMA: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women

NCT ID: NCT03144648

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-12
• Study Completion Date: 2025-12-30

Brief Summary

Breast cancer has become a major public health problem in Latin America, as it is the most common form of cancer among women. Women are more likely to develop breast cancer at younger age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty years, the mortality from breast cancer in Latin America has also been increasing very rapidly, and is currently the leading cause of cancer mortality. Little is known on specific risk factors for premenopausal breast cancer in general, and in Latin America in particular. There is a lack of specific knowledge on tumor molecular and pathological characteristics of breast cancer in Latin America premenopausal women, and this has major consequences on cancer treatment and survival.

To improve our understanding on determinants of breast cancer incidence and mortality in young Latin America women and support preventive actions, we implemented an international, population-based multi-center study in Latin America: the PRECAMA study (Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter population-based case-control study).

PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major aims of the project are the following:

1. To develop a multi-centric population-based case-control study on breast cancer in premenopausal women in several countries in Latin America with structured collection of individual, clinical, pathological information and biological specimens, according to strictly controlled protocols

2. To characterize, in these populations, the subtypes of premenopausal breast cancer on the basis of their molecular and pathological phenotypes

3. To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes.

4. Provide advanced training, induce a structuring effect on the breast cancer research community in Latin America and influence the public health agenda regarding the management of breast cancer.

The results of our study will be of utmost importance to understand the etiology of breast cancer in Latin America countries, and would provide important information on the role of modifiable exposures for breast cancer prevention.

Detailed Description

Breast cancer (BC) has become a major public health problem in Latin America (LA), as it is the most common form of cancer among women. In Women are more likely to develop BC at younger age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty years, the mortality from BC in LA has also been increasing very rapidly, and is currently the leading cause of cancer mortality among LA women. The large number of incident BC cases among premenopausal women, which is only partly explained by the population age-structure, is therefore of major concern. Little is known on specific risk factors for premenopausal BC in general, and in LA in particular, and risk factors related to diet, obesity and low physical activity play a role on incidence and mortality. Estrogen receptor (ER) and/or Progesterone receptor (PR) expression in breast tumors may differ according to risk factors and to molecular pathological characteristics. There is a lack of specific knowledge on tumor molecular and pathological characteristics of BC in premenopausal women, particularly in lower resource countries where the hormone-dependence status is poorly documented. This has major consequences on cancer treatment and survival.

To improve our understanding of determinants of BC incidence and mortality in young Latin America women and support preventive actions, we implemented an international, population-based multi-center case-control study in LA: the PRECAMA study (Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter population-based case-control study).

PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major aims of the project are the following:

1. To develop a multi-centric population-based case-control study on BC in premenopausal women in several countries in LA with structured collection of individual, clinical, pathological information and biological specimens, according to strictly controlled protocols

2. To characterize, in these populations, the subtypes of premenopausal BC on the basis of their molecular and pathological phenotypes

3. To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes.

4. Provide advanced training, induce a structuring effect on the BC research community in LA and influence the public health agenda regarding the management of BC.

Standardized methods and questionnaires have been developed and implemented as well as standard operating procedures for laboratory activities. Incident primary invasive cases aged 20-45 years are recruited from major cancer hospitals in four large Latin American cities (Mexico City, San Jose, Medellin, and Santiago) prior to any treatments. Controls for the study are selected from the population residing in the same cities for at least 3 years and matched to cases on age (+/- 5 years) and health care institution. For each subject, complete questionnaire data on socio-demographic factors, health history, reproductive history, use of hormones, early risk factors, body silhouette at different ages, physical activity, diet, occupation, environmental risk factors, ethnicity, and family history of cancer are collected. Validated and standardized food frequency questionnaires are administered to gather information on diet. Anthropometry (body weight, standing and sitting height, waist and hip circumferences) are measured according to standardized protocols. Blood and urine samples are also collected for biomarker analyses. For all cases, highly standardized immunohistochemical and molecular analyses are performed to identify BC subtypes.

The results of our study will be of utmost importance to understand the etiology of breast cancer in Latin America countries in epidemiological transition, and would provide important information on the role of modifiable exposures on the disease which may provide important support for breast cancer prevention.

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Cases

Incident primary invasive breast cancer cases aged 20-45 years are recruited from major cancer hospitals in five Latin American cities (Barretos, Mexico City, San Jose, Medellin, and Santiago) prior to any treatments. For each subject, complete questionnaire data on socio-demographic factors, health and reproductive history, early risk factors, physical activity, diet, environmental risk factors, ethnicity, and family history of cancer are collected. Validated and standardized food frequency questionnaires are administered to gather information on diet. Anthropometry is measured according to standardized protocols. Blood and urine samples are also collected for biomarker analyses. Highly standardized immunohistochemical and molecular analyses are performed to identify cancer subtypes

lifestyle

Intervention Type: OTHER

Observational study

Controls

Women with no cancer recruited from the population residing in the same cities for at least 3 years and matched to cases on age (+/- 5 years) and health care institution. For each subject, complete questionnaire data on socio-demographic factors, health and reproductive history, early risk factors, physical activity, diet, occupation, environmental risk factors, ethnicity, and family history of cancer are collected. Validated and standardized food frequency questionnaires are administered to gather information on diet. Anthropometry is measured according to standardized protocols. Blood and urine samples are also collected for biomarker analyses.

lifestyle

Intervention Type: OTHER

Observational study

Interventions

lifestyle

Observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• woman between 20 and 45 years old
• woman less than 3 years older or younger than the case
• living in the area that the study is taking place during the past 3 years
• woman menstruated at least once in the past 12 months
• woman diagnosed with a primary breast cancer by histopathological examination (only for cases)

Exclusion Criteria

• woman receiving tumor treatment, such as radiotherapy, chemotherapy or anti-estrogens (for example, tamoxifen) (except treatment for non-melanoma skin cancers)
• woman taking (or has previously taken) any of the following medications in the past 6 months: tamoxifen, Evista (raloxifene), Fareston (toremifene), Aromasin (exemestane), Femara (letrozole), Arimidez (anastrozole) or Megace (megestrol)
• woman suffering from chronic kidney failure
• woman having a pathology that will hinder adequate communication
• woman who is pregnant or nursing
• woman who has been previously diagnosed with a cancer(except for non-melanoma skin cancers)
• any other reason to exclude

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chile

OTHER

Sponsor Role: collaborator

Fundación Inciensa

OTHER

Sponsor Role: collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role: collaborator

Universidad de Antioquia

OTHER

Sponsor Role: collaborator

Barretos Cancer Hospital

OTHER

Sponsor Role: collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabina Rinaldi, PhD

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer, Lyon, France

Maria Luisa Garmendia, PhD

Role: PRINCIPAL_INVESTIGATOR

INTA, Universidad de Chile, Santiago, Chile

Carolina Porras, PhD

Role: PRINCIPAL_INVESTIGATOR

Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica

Gabriela Torres-Mejía, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Salud Pública, Cuernavaca, Mexico

Gloria I Sánchez, PhD

Role: PRINCIPAL_INVESTIGATOR

Grupo Infección y Cáncer, Universidad de Antioquía, Medellín, Colombia

Fabiana Vazquez

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

Barretos Cancer Hospital

Barretos, , Brazil

Site Status: COMPLETED

INC

Santiago, Independencia, Chile

Site Status: ACTIVE_NOT_RECRUITING

Hso-Crsco

Santiago, Peñalolén, Chile

Site Status: ACTIVE_NOT_RECRUITING

FALP

Santiago, Providencia, Chile

Site Status: ACTIVE_NOT_RECRUITING

Grupo Infección y Cáncer. Universidad de Antioquia

Medellín, Antioquia, Colombia

Site Status: RECRUITING

International Hospital of Colombia

Bucaramanga, Bucaramanga, Colombia

Site Status: RECRUITING

Facultad de Medicina, Universidad del Norte

Barranquilla, , Colombia

Site Status: COMPLETED

Hospital Internacional de Colombia Fundacion Cardiovascular de Colombia

Bucaramanga, , Colombia

Site Status: RECRUITING

SENOSAMA foundation

Bucaramanga, , Colombia

Site Status: RECRUITING

Instituto de Oncología HematoOncologos

Cali, , Colombia

Site Status: COMPLETED

Public Health University of Narino

Pasto, , Colombia

Site Status: RECRUITING

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

San José, Provincia de San José, Costa Rica

Site Status: COMPLETED

Instituto Nacional de Salud Pública (INSP)

Cuernavaca, Morelos, Mexico

Site Status: COMPLETED

Countries

Brazil; Chile; Colombia; Costa Rica; Mexico

Central Contacts

Sabina Rinaldi, PhD

Role: CONTACT

rinaldis@iarc.who.int

+33 472738485 ext. 8328

Facility Contacts

Gloria Sanchez, MSc, PhD

Role: primary

gloria.sanchez@udea.edu.co

+57 3014201831

Maria Agudelo, MD

Role: backup

ceci886@hotmail.com

+57 3012974825

Ana I Orduz

Role: primary

Norma C Serrano

Role: primary

Claudia Amaya

Role: primary

Alvaro Paz

Role: primary

Related Links

http://precama.iarc.fr

Related Info

Other Identifiers

PRECAMA

Identifier Type: -

Identifier Source: org_study_id