Breast Cancer
Conditions
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
Brief 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.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* ELIGIBILITY CRITERIA: ELIGIBILITY CRITERIA FOR PART A OF THE STUDY: INCLUSION CRITERIA: * Women age greater than or equal to 18 years. * AJCC 7 clinical stage II or III breast cancer. Clarification: Participants with clinical stage II breast cancer who are later classified as histologically-confirmed stage I will remain on study; participants who are later classified as histologically-confirmed stage IV breast cancer will be taken off study. * Biopsy-accessible breast tumor or participant candidates for primary surgery. * Eastern Cooperative Oncology Group (ECOG) performance status 0 1.
Exclusion criteria
* Prior history of non-breast malignancy (excluding in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to enrollment in this study. * Bilateral invasive or in-situ breast cancer. * Inflammatory breast cancer. * Clinical or radiological evidence of distant metastases by computed tomography (CT), chest X-ray, abdominal/thoracic ultrasound, bone scan, and/or liver function tests including total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP), within ranges defined in eligibility criteria for Part B of the study. * Prior hormone therapy, chemotherapy, biologic, targeted therapies, or radiation therapy for this malignancy. Prior bisphosphonate therapy is allowed. * Pregnant and lactating women: Effects on a developing human fetus of chemotherapeutic agents at the recommended therapeutic dose remain incompletely defined. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to study entry and for the duration of study treatment phase. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. * Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapeutic agents, women who are breastfeeding will be excluded. If a participant is of child-bearing potential (women are not considered of childbearing potential if they are at least 2 years postmenopausal and/or surgically sterile), she must have documented negative serum or negative urine pregnancy tests within 14 days of entry to the study (i.e., within 14 days of signing the informed consent document). * Subjects with psychiatric illness and/or other specific situations that would limit compliance with study requirements and compromise participant follow-up. * Lack of ability to understand and willingness to sign a written informed consent document. Note: Subjects who were enrolled prior to this amendment will be considered eligible even if the HIV/Hep C and pregnancy test were not preformed due to each country standards. ELIGIBILITY CRITERIA FOR PART B OF THE STUDY: Participants, who successfully enrolled into the first part of the study and who, according to local institutional guidelines, are candidates for neoadjuvant chemotherapy will participate in Part B of the study. Participants must also meet the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize distribution of invasive breast cancer stage II and III molecular profiles | 2 years post accrual closure | This project will provide valuable information on the effectiveness of standard chemotherapy in Latin American women. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants in each molecular profile who achieve pCR to neoadjuvant chemotherpay | 2 years post accrual closure |
| RCB following neoadjuvant chemotherapy | 2 years post accrual closure |
| Association of molecular profile with tumor histological type, size,lymph node status and surrogate markers | 2 years post accrual closure |
| Survival-OS, DFS, and TFF | 2 years post accrual closure |
| Demographic and epidemiological characteristics of the population by molecular profile | 2 years post accrual closure |
| Predictive and prognostic gene expression signatures | 2 years post accrual closure |
Countries
Argentina, Brazil, Chile, Mexico, Uruguay
Outcome results
None listed