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This research study is studying a combination of drugs as a possible treatment for metastatic triple-negative breast cancer. The drugs involved in this study are: - Cabozantinib (XL184) - Nivolumab
The purposes of this study are to assess the safety, tolerability of combining Hemay022 with exemestane in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR( Optimal Tolerated Regimen). The secondary purpose of this study is to assess the pharmacokinetics and efficacy of combining Hemay022 with exemestane. The study will be conducted in two parts. Part one, trial will be conducted in 15-24 subjects to determine safety and tolerability of combining Hemay022 with exemestane in patients with HER2-positive advanced breast cancer. Part two, approximately 24 additional subjects with ER and HER2-positive advanced breast cancer, are included to better define the tolerability and preliminary efficacy of Hemay022.
We aim to assess the quality of life (QoL), and presence and severity of anxiety and depressive symptoms, in women who have had breast cancer diagnosed at ≥1 year, compared to women who did not have cancer. The Clinical Practice Research Datalink (CPRD) primary care database will be used to select a random sample of breast cancer survivors (≥1 year), whose general practitioner (GP) agrees to participate in the study (see below), and who were registered with the practice for ≥1 year before and after the breast cancer diagnosis. Age-matched women who never had cancer will be randomly selected from the same practice. Staff at each practice will mail the study materials to the eligible women, who will complete the questionnaires and send those to the CPRD Intervention Studies Team for processing. Studies of patient reported outcomes (PROs) have been limited by the high cost, time and logistics involved in recruiting patients and processing data. We will evaluate the feasibility of collecting these data using electronic questionnaires rather than paper ones. Thus, nearly half of the participants will receive paper questionnaires, while the others will receive instructions on how to complete the questionnaires online. We will compare the participation rate by each method. In addition, a secondary objective of this study is to assess whether PROs can be reasonably studied by using electronic health records (EHR) or by inquiring the patients' GP, as any of these would involve fewer resources. For this, the EHR of the participating women will be collated from the CPRD primary care database, and the GPs of the participating women will report on their awareness of the patient's anxiety and depressive disorders, or distress for QoL domains; the results of the two sources will be compared to those reported by the patients.
This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.
Routine incorporation of decision aids into oncology practice has the potential to significantly improve patients' experiences with cancer by increasing the likelihood that they make informed treatment decisions aligned with their values. Unfortunately, only a minority of the more than 1.6 million patients diagnosed annually with cancer ever receive one due to limited clinic resources for administration and challenges in timely identification of appropriate patients. Online delivery directly to patients addresses some of these barriers but is insufficient on its own to ensure accessibility for patients at the time they most benefit from support.19 It is critical that active, multi-faceted implementation strategies that target barriers to the widespread use of web-based decision aids be identified, as these tools have the potential to significantly improve the quality of oncologic care. Based on strong preliminary work, the investigators have developed and piloted a package of implementation strategies that effectively overcomes barriers to delivery of a web-based breast cancer surgery decision aid in an academic and community clinic. Although the strategy was successful, patients were white and educated; further investigation is imperative in settings that provide care to underserved patients to ensure the intervention will mitigate, rather than worsen, existing disparities in breast cancer care. This is especially critical given that underserved patients may benefit most from shared decision-making interventions such as the one described. To study this, the investigators propose a pilot study within a clinic that serves a catchment area with a high proportion of African American, rural and low income patients. The investigators will iteratively assess and enhance our implementation package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient and clinic level barriers to implementation of a web-based breast cancer surgery decision aid in a clinic that cares for underserved patients, and 2) To test and expand our current implementation package's ability to address barriers in a clinic that cares for underserved patients. The investigators will determine the reach of implementation and acceptability of this method of decision aid delivery to stakeholders.
The MARIA breast imaging system is a novel CE-marked radio-frequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The performance and imaging characteristics of MARIA are not yet well demonstrated. The investigators aim to evaluate some aspects of this potentially important new technology.
This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.
Background: Exomes are the parts of DNA that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Researchers want to use pieces of participants tumors to find the tumor-specific mutations. They also will take participants white blood cells to make a vaccine that they hope will shrink the tumors. Objectives: To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors to shrink. Eligibility: Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer Design: The first part of this study was done under protocol 03-C-0277. In that study, white blood cells and pieces of participants tumors were taken to make a vaccine. In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given both in a vein and under the skin. At each visit, participants will have a physical exam and have blood taken. They will talk about any side effects they have. After treatment ends, participants will have many follow-up visits for the first year, then once each year after that. Visits will last up to 2 days each. They will include lab tests, imaging studies, and a physical exam. Blood will be taken at each visit. At the first follow-up visit, participants may have leukapheresis, which they also had as part of protocol 03-C-0277. Participants may not have to return to the Clinical Center for these visits.
The purpose of this study is to evaluate feasibility to treat metachronous multi-site breast cancer oligometastasis with stereotactic body radiotherapy (SBRT) in patients on systemic therapy.
This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with FDG-labeled RBC in patients with breast cancer. Cardiac ejection fraction can be calculated and monitored in breast cancer patients during chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if calculated cardiac ejection fraction shows high concordance with results from echocardiography.