Breast Cancer FemalePRECAMANCT03144648
PRECAMA: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women
An observational study of Breast Cancer Female, run by International Agency for Research on Cancer at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- lifestyle
- How many people
- 3,000 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 12 Oct 2012to 30 Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Premenopausal Latin America women
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 5 countries
Colombia7 sites, 5 recruiting
- Completed
Facultad de Medicina, Universidad del Norte
Barranquilla
- Recruiting
International Hospital of Colombia
Bucaramanga, Bucaramanga
Ana I Orduz
- Recruiting
Hospital Internacional de Colombia Fundacion Cardiovascular de Colombia
Bucaramanga
Norma C Serrano
- Recruiting
SENOSAMA foundation
Bucaramanga
Claudia Amaya
- Completed
Instituto de Oncología HematoOncologos
Cali
- Recruiting
Grupo Infección y Cáncer. Universidad de Antioquia
Medellín, Antioquia, 050010
Gloria Sanchez, MSc, PhD, +57 3014201831, gloria.sanchez@udea.edu.co
Maria Agudelo, MD, +57 3012974825, ceci886@hotmail.com
- Recruiting
Public Health University of Narino
Pasto
Alvaro Paz
Chile3 sites
- Active, not recruiting
INC
Santiago, Independencia
- Active, not recruiting
Hso-Crsco
Santiago, Peñalolén
- Active, not recruiting
FALP
Santiago, Providencia
Costa Rica1 site
- Completed
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
San José, Provincia de San José
Mexico1 site
- Completed
Instituto Nacional de Salud Pública (INSP)
Cuernavaca, Morelos, 69100
About this study
Official title: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a Multicenter Population-based Case-control Study
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).
Read more
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:
- 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
- To characterize, in these populations, the subtypes of premenopausal breast cancer on the basis of their molecular and pathological phenotypes
- To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes.
- 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.
Read the 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:
- 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
- To characterize, in these populations, the subtypes of premenopausal BC on the basis of their molecular and pathological phenotypes
- To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes.
- 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
- Being tested
- lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyleOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer
breast cancer
Measured: at recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start12 Oct 2012
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, Fundación Inciensa, Instituto Nacional de Salud Publica, Mexico, Universidad de Antioquia, Barretos Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Sabina Rinaldi, PhD, Principal investigator, International Agency for Research on Cancer, Lyon, FranceMaria Luisa Garmendia, PhD, Principal investigator, INTA, Universidad de Chile, Santiago, ChileCarolina Porras, PhD, Principal investigator, Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa RicaGabriela Torres-Mejía, PhD, Principal investigator, Instituto Nacional de Salud Pública, Cuernavaca, MexicoGloria I Sánchez, PhD, Principal investigator, Grupo Infección y Cáncer, Universidad de Antioquía, Medellín, ColombiaFabiana Vazquez, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144648
- Sponsor's protocol ID
- PRECAMA
- Acronym
- PRECAMA
- Status last verified
- May 2025
- First submitted
- 5 May 2017
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No