Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Background:

      - Researchers want to learn more about breast cancer in Latin American women. They also want
      to learn how and why women respond differently to standard treatment. Tissue and blood
      samples from women with breast cancer are needed to study this disease in order to find new
      ways to prevent, diagnose, and treat it.

      Objective:

      - To learn more about the biology and genetics of breast cancer in Latin American women.

      Eligibility:

      - Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II
      or III breast cancer. They must still be active and able to self-care.

      Design:

        -  Participants are only agreeing to have extra tissue or blood samples collected. They are
           also letting tissue left over from surgery be used for research. No procedures outside
           of standard care will be done.

        -  Participants may have a medical history, physical exam, and blood tests. They may have a
           pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have
           an intravenous needle placed in an arm vein.

        -  Participants may have a core biopsy. For this, a needle is inserted into the breast. A
           piece of tissue is extracted.

        -  Participants who have chemotherapy may have blood taken after treatment/before surgery.
           Tissue may also be collected.

        -  Participants will complete a questionnaire. It will ask about their social and economic
           background. It will ask about their family history of cancer. It will also ask about
           access to diagnosis and treatment of breast cancer.

        -  Participants may be followed for up to 5 years.
    

Detailed description: 
      The primary objective of this study is to characterize the distribution of molecular profiles
      in Latin American women with AJCC 7 clinical stage II or III breast cancer. The molecular
      profiles will be correlated with epidemiological, histological, and clinical characteristics,
      including pathologic response to standard neoadjuvant chemotherapy. Moreover, this study
      intends to define a molecular signature that will predict response to neoadjuvant therapy in
      breast cancer. This is a prospective cohort study in which no investigational drugs will be
      administered to participants. The study will be conducted at participating institutions in
      Argentina, Brazil, Chile, Mexico, and Uruguay.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The primary objective of the study is to characterize the distribution of invasive breast
        cancer stage II or III by immunohistochemistry and gene expression profiles in Latin
        American women. The study has two parts: Part A is a descriptive, observational part to
        characterize the molecular profile of breast cancer in Latin American women; Part B, the
        standard neoadjuvant chemotherapy treatment part of the study, seeks to identify any
        associations between response to neoadjuvant therapy and the molecular profiles.
        Participants will be followed for a period of 5 years to determine any associations between
        the molecular profiles and disease evolution following standard treatment.
      
Keywords: Molecular Profiles of Breast Cancer in Latin American Women; AJCC 7 Clinical Stage II to III; Breast Cancer Observational Study; Prospective Cohort; Epidemiological, Histological, and Clinical Data