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The purpose of this study is to test the effectiveness of Mi Vida Saludable (My Healthy Life), a program designed to help Latina/Hispanic breast cancer survivors eat a healthy diet and be physically active. The Mi Vida Saludable program includes four weeks of hands-on and in-person nutrition and physical activity education classes and 11 months of electronic communication via text messaging, emails, and a website.
The American Cancer Society and the American Institute for Cancer Research recommend a diet for cancer survivors high in fruits/vegetables and low in energy-dense foods, including high-fat foods and red meats. The rationale is that this diet will reduce cancer recurrence risk, improve survival rates, and reduce comorbid conditions, including heart disease and metabolic disorders. Proposed mechanisms of action include inflammatory, oxidative stress, hormonal and metabolic pathways. Despite these guidelines, recent studies show that, on average, breast cancer survivors in the US eat diets similar to most Americans, which are low in fruits/vegetables and high in energy-dense foods. Many cancer survivors lack the nutrition education and skills needed to make sustainable dietary change. In addition, the mediators by which some individuals are able to achieve change, compared to those who are not, are not clearly understood. Current nutrition education resources for patients differ by medical institution and region, and are often absent. The American Society for Clinical Oncology guidelines recently emphasized that effective health promotion education programs for cancer survivors are needed.
We conducted a pilot randomized controlled trial of a hands-on nutrition education program among female Hispanic breast cancer survivors (R21CA152903, n=70). We will use pilot data from our trials to test an expanded intervention in a more generalizable population of breast cancer survivors to identify the optimal dose and delivery method of the intervention and how to maintain the intervention’s effect over a longer period of time.
Aim 1: Determine the optimal dose and delivery method of Cook For Your Life! in a diverse group of breast cancer survivors (n=300).
Aim 2: Examine predictors and mediators of dietary change among subgroups, including income, education, ethnicity, acculturation, stress, life events, self-efficacy, locus of control, social support and perceived benefits of dietary change. Exploratory analyses will examine the role of cognitive and executive function as predictors and mediators of dietary change.
Aim 3: We will examine the effects of the intervention on inflammatory and oxidative stress biomarkers associated with breast cancer recurrence risk.
IMPACT: There are limited data to suggest how to teach cancer survivors to make sustainable dietary changes in order to meet and maintain dietary guidelines. We propose a novel, standardized method to implement dietary change among an ethnically and linguistically diverse group of cancer survivors. If effective, the standardized curriculum can be implemented by community groups and medical centers. If warranted, study results will be used to design a multi-site dietary intervention among a larger and more diverse population of cancer survivors.
The purpose of this study is to see whether neratinib is effective in treating HER2-negative metastatic tumors that have this specific HER2 mutation. The first part of the study is a preliminary screening. During this part of the study, your tumor tissue will be tested to see if it has the HER2 mutation the researchers are looking for. If your tumor has the mutation, you will be given more information about the main research study, which is investigating the effectiveness of neratinib.
The research team proposes to conduct a single arm 2-stage Phase 2 trial of neratinib in metastatic but HER2 non-amplified but HER2 mutant breast cancer. Pre-registration is required for tumor HER2 sequencing. The primary objective is clinical benefit rate (CBR: rate of complete response plus partial response and stable disease > 6 months). With an 80% power and a 1-sided 0.05 significance level, the first stage of 10 patients and the 2nd stage of 19 patients are planned to test an anticipated CBR of 20% versus the null hypothesis of 5%. Secondary endpoints include progression free survival and the molecular epidemiology of HER2 mutation. Exploratory endpoints include mechanisms of treatment resistance and other somatic mutations in HER2 negative disease. Because the mutation frequency is approximately 2%, they anticipate screening of 1500 patients to identify the 29 patients with the HER2 mutation and eligible for study drug therapy. The success of this trial could establish a new treatment option for a subset of patients with HER2 non-amplified tumors.
The goal of this study is to learn more about breast cancer in Hispanic women by studying Hispanic women with breast cancer and Hispanic women who have never had breast cancer. The research team has enrolled Hispanic women with breast cancer for the study. Now, they need Hispanic women who have never had any type of cancer (skin cancers are okay).
With advances in technology, genomics is becoming increasingly important for personalized medicine, both for determining risk of developing disease and for making treatment-related decisions. In order to better prevent and treat breast cancer, we need to identify individuals who are at high risk due to inherited genetic mutations. In this proposal, we will focus on breast cancer in Hispanic women. Although Hispanics represent the fastest growing ethnic population in the U.S., they have been largely understudied in terms of genetic susceptibility to cancer even though breast cancer is the most common cancer and causes the most cancer deaths in Hispanic women. The overall long-term goal of this project is the development of a comprehensive clinical genetic test that provides a set of susceptibility genes for inherited breast cancer and can be readily integrated into clinical practice. Specific Aim 1 is to identify variants in 605 genes involved in DNA damage response pathways using next-generation sequencing. We will use DNA from 1000 Latina breast cancer patients and 1000 healthy Latina controls. Specific Aim 2 is to identify the set of variants of biological significance through in silico analyses. Specific Aim 3 is to perform gene-based association tests of the genes and risk to develop breast cancer.
The purpose of the study is to learn what genetic factors may play a role in the development of breast cancer in young women.
The researchers need to recruit 5,000 women who were diagnosed with invasive breast cancer when they were 40 years old or younger for this study.
Breast cancer takes its greatest toll on young women. Young women frequently have biologically aggressive tumors. They often present with advanced disease and their tumors are frequently hormone non- responsive, thereby limiting treatment options. Young women suffer lower than average disease-free and overall survival. The work proposed is focused on discovery of the as yet unknown genetic risk factors that underlie development of early-onset breast cancer. These findings will pave the way for future studies to elucidate how genetic risk and environmental factors interact and account for the aggressive tumors and poor outcome young breast cancer patients experience. We hypothesize copy number variants (CNVs) play an important role in risk for development of early-onset breast cancer.