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

NCT03144648 | Recruiting

• 1 other identifier: PRECAMA
• Study Type: observational
• Target: 3,000
• Locations: 4 countries
• Sites: 12

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. 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. 2.To characterize, in these populations, the subtypes of premenopausal breast cancer on the basis of their molecular and pathological phenotypes
3. 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. 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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• breast cancer

  breast cancer

  at recruitment

Study Arms (2)

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

Other: lifestyle

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.

Other: lifestyle

Interventions

lifestyle OTHER

Observational study

Cases; Controls

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Premenopausal Latin America women

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• University of Chile: collaborator
• Fundación Inciensa: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator
• Universidad de Antioquia: collaborator
• Barretos Cancer Hospital: collaborator

Study Sites (13)

Barretos Cancer Hospital

Barretos, Brazil

COMPLETED

INC

Santiago, Independencia, Chile

ACTIVE NOT RECRUITING

Hso-Crsco

Santiago, Peñalolén, Chile

ACTIVE NOT RECRUITING

FALP

Santiago, Providencia, Chile

ACTIVE NOT RECRUITING

Grupo Infección y Cáncer. Universidad de Antioquia

Medellín, Antioquia, 050010, Colombia

RECRUITING

International Hospital of Colombia

Bucaramanga, Bucaramanga, Colombia

RECRUITING

Facultad de Medicina, Universidad del Norte

Barranquilla, Colombia

COMPLETED

Hospital Internacional de Colombia Fundacion Cardiovascular de Colombia

Bucaramanga, Colombia

RECRUITING

SENOSAMA foundation

Bucaramanga, Colombia

RECRUITING

Instituto de Oncología HematoOncologos

Cali, Colombia

COMPLETED

Public Health University of Narino

Pasto, Colombia

RECRUITING

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

San José, Provincia de San José, Costa Rica

COMPLETED

Instituto Nacional de Salud Pública (INSP)

Cuernavaca, Morelos, 69100, Mexico

COMPLETED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, red blood cells, buffy coats, urine, and for cases, DNA from tumor tissues

Study Officials

• Sabina Rinaldi, PhD

  International Agency for Research on Cancer, Lyon, France

  PRINCIPAL INVESTIGATOR

• Maria Luisa Garmendia, PhD

  INTA, Universidad de Chile, Santiago, Chile

  PRINCIPAL INVESTIGATOR

• Carolina Porras, PhD

  Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica

  PRINCIPAL INVESTIGATOR

• Gabriela Torres-Mejía, PhD

  Instituto Nacional de Salud Pública, Cuernavaca, Mexico

  PRINCIPAL INVESTIGATOR

• Gloria I Sánchez, PhD

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

  PRINCIPAL INVESTIGATOR

• Fabiana Vazquez

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabina Rinaldi, PhD

CONTACT

+33 472738485; rinaldis@iarc.who.int

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: October 12, 2012
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (7); ME (1); CL (3); BR (1)