View clinical trials related to Locally Advanced Breast Cancer.
Filter by:This study is a Phase 1b open label, single arm, adaptive multi-centre trial of copanlisib in combination with trastuzumab emtansine (T-DM1) in pretreated locally advanced or metastatic HER2-positive breast cancer. Patients with unresectable locally advanced or metastatic HER2-positive breast cancer who previously received trastuzumab and a taxane, separately or in combination, will be treated with copanlisib (to the dose escalation scheme) plus trastuzumab emtansine 3.6mg/kg IV on day 1 of a 21-day cycle.
Primary Objective: • Determination of pathologic complete response (pCR) rates Secondary Objective: - Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and troponin. - Breast conservation rates - Overall survival Study Design - Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will be enrolled. - Patients will be stratified by ER/PR status. - They will be randomized to ddACTHP vs TCHP. - Initially, 17 patients will be randomly assigned to each treatment arm. - If 3 or fewer patients have a pCR, then that arm will be terminated and no further patients will be entered on that treatment arm. - If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients) will be randomized to that treatment arm. - If 11 or more patients out of 37 have a pCR, the treatment will be of interest for further study.
The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.
Aberrant DNA methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase II study, the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess their safety and biological efficacy.