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The purpose of this study is to investigate the relationship between your cardiovascular fitness and your body’s immune response, as both may be related to fatigue (tiredness), mood, pain sensitivity, memory, and concentration—known side effects of cancer and its treatments. By learning if people with better cardiovascular fitness have lower inflammation, researchers will be able to discover whether and how regular exercise benefits breast cancer survivors.
This double-blind, randomized, crossover trial will evaluate inflammatory and behavioral responses to typhoid and placebo inoculations as a function of cardiorespiratory fitness, age, and depression in breast cancer survivors. The aims of the project are (1) to evaluate the relationships between cardiorespiratory fitness and inflammatory and behavioral responses (negative mood, fatigue, pain, and cognitive problems) to typhoid vaccine; (2) to determine the effects of age and depressive symptoms on inflammatory and behavioral responses to typhoid vaccine and placebo; and (3) to assess the ability of cardiorespiratory fitness to moderate age- and depression-related responses to typhoid vaccine. These questions are important because inflammation, a robust and reliable predictor of all-cause mortality in older adults, is one of the key candidate mechanisms for age-related decrements in physical function and disability. Individuals frequently encounter immune challenges in daily life, and the ability to minimize inflammatory responsiveness influences the total burden that infectious challenges or tissue injury place on an individual. Larger, more frequent, or more persistent inflammatory changes have negative consequences for health. If better cardiorespiratory fitness dampens or limits inflammatory responsiveness, then this study could demonstrate a new and novel mechanism through which regular exercise produces its substantial health benefits.
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.