Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,334
- 试验地点
- 9
- 主要终点
- Characterize distribution of invasive breast cancer stage II and III molecular profiles
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Characterize distribution of invasive breast cancer stage II and III molecular profiles
时间窗: 2 years post accrual closure
This project will provide valuable information on the effectiveness of standard chemotherapy in Latin American women.
次要结局
- 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)
- Association of molecular profile with tumor histological type, size,lymph node status and surrogate markers(2 years post accrual closure)
- Demographic and epidemiological characteristics of the population by molecular profile(2 years post accrual closure)