Phase 2 Study - Aurora + Angiogenic Kinase Inhibitor ENMD-2076 in Previously Treated Locally Advanced...
Triple Negative Breast CancerThe purpose of this study is to determine the activity of ENMD-2076 as defined by the clinical benefit rate when patients with previously treated locally advanced or metastatic triple negative breast cancer are treated with daily oral ENMD-2076.
Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer
Triple-negative Breast CancerEvaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of breast cancer cells in women with Stage I, II, or III triple negative breast cancer.
Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Chemotherapy in Triple Negative Breast...
Breast CancerTo date no targeted agents are available to treat TNBC. Therefore chemotherapy is the only treatment option. TNBC often has a high amount of tumour infiltrating lymphocytes. Stimulating the immune cells of TNBC might therefore be an option for these patients to increase the pathological complete response. pCR is highly correlated with outcome in TNBC. Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an additional option for these patients.
Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer...
Triple Negative Breast CancerThe purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.
A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors
Triple-Negative Breast NeoplasmsCarcinoma4 moreThe purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in participants with advanced solid tumors.
Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR
Breast NeoplasmsTriple Negative Breast NeoplasmsPrimary Objective: To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear translocation of the epidermal growth factor receptor (EGFR) in Stage I-III, nuclear EGFR positive, triple negative breast cancers (TNBC). Secondary Objectives: To examine the safety and tolerability of dasatinib in patients with operable TNBC To explore potential intracellular mechanisms which impact dasatinib effect on cellular localization of EGFR in operable TNBC. To examine the pathologic complete response (pCR) rates to standard neoadjuvant chemotherapy in nEGFR+ TNBC To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+ TNBC
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
Breast CancerInvasive Breast Cancer1 moreThis study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at the effects of entinostat on tumor tissue for research purposes only. Approximately 246,660 cases of breast cancer were diagnosed in the United States in 2016. Its detection and treatment remains a major concern in women's healthcare. In particular, TNBC accounts for approximately 15-20% of all breast cancers. Research into treatment for breast cancer relies more and more on understanding how the cancer cells act when they are exposed to an anti-cancer drug. How most cancer cells act when exposed to anti-cancer drugs and which patients as a result may benefit the most from these drugs is not well known. Additional studies are required to determine the cells' reactions. The purpose of part 1 of this study is to better understand how TNBC tumors react to one particular cancer drug, entinostat. Entinostat is currently being studied across multiple clinical trials for the treatment of breast cancer, other solid tumors and blood cancers. Entinostat is investigational and has not yet been FDA approved for the treatment of cancer. Studies have shown that a good way to determine how cancer acts when exposed to anti-cancer drugs is a short-term preoperative window study. In this type of study, subjects receive a study drug a couple of days before surgery. Leftover tissue from surgery is then used to determine some of the effects that a study drug may have on the tumor. In this study, subjects will receive two doses of entinostat prior to undergoing planned surgery. Leftover tissue from this surgery will then be used to determine the effects entinostat has on tumor cells. For example, the study team will examine if the types of genes and proteins that the tumor expresses as a result of entinostat exposure increases or decreases the likelihood that the tumor will not continue to grow. A gene is a unit of DNA. Genes make up the chemical structure carrying your genetic information that may determine human characteristics (i.e., eye color, height and sex). This study will focus on discovering how entinostat affects a wide variety of genes in tumor cells.
A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer
Breast CancerTriple Negative Breast CancerGiven preliminary data demonstrating that methionine deprivation enhances cell surface expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that methionine restriction enhances its expression in triple negative breast cancer and to establish the feasibility and acceptability of this dietary intervention in humans. This study will also examine the effect of methionine restriction on cancer stem cells and metabolic health.
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects...
Advanced Solid TumorMetastatic Cancer15 moreThe purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the preliminary efficacy for each combination regimen.
Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy...
Triple Negative Breast CancerTriple Negative Breast Neoplasms1 moreThe most important consideration in the design of this clinical trial is to ensure the safe translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug Administration (FDA) dictates that initial studies of biologic therapies be performed in such a way that there is a balance between the potential risks and benefits in individual patients. Consistent with these recommendations, the investigators will target patients with triple-negative breast cancer who do not have a pathologic complete response after neoadjuvant chemotherapy. These patients typically have no gross evidence of disease following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy) but are at extremely high-risk for disease recurrence. Targeting this patient population provides a window-of-opportunity to design and manufacture the personalized cancer vaccines, maximizes the potential benefit from the vaccine as the regulatory networks associated with metastatic disease are not present, and balances risk in this patient population with extremely high risk for disease recurrence but no other treatment options.