Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02326857
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2014-12-23
• Primary Completion: 2014-12-23
• Study First Submitted: 2014-12-25
• Study First Submitted QC: 2014-12-25
• Study First Posted: 2014-12-30
• Status Verified: 2020-09
• Study Completion: 2020-09-23
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1334

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Predictive and prognostic gene expression signatures	2 years post accrual closure
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
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
Association of molecular profile with tumor histological type, size,lymph node status and surrogate markers	2 years post accrual closure

Trial Locations

Locations (9)

Instituto Jalisciense de Cancerologia; 🇲🇽 Guadalajara, Mexico

Instituto do C(SqrRoot) ncer do Estado de S(SqrRoot) o Paulo; 🇧🇷 Sao Paulo, Brazil

Universidad de Guadalajara; 🇲🇽 Guadalajara, Mexico

Instituto Leloir; 🇦🇷 Buenos Aires, Argentina

Instituto Nacional de Cancer (INCA); 🇧🇷 Rio de Janeiro, Brazil

Instituto de Salud Publica; 🇨🇱 Santiago, Chile

Instituto Pasteur de Montevideo; 🇺🇾 Montevideo, Uruguay

Institito Nacional de C(SqrRoot)(Degree)ncer; 🇺🇾 Montevideo, Uruguay

Universidad de Sonora; 🇲🇽 Sonora, Mexico