Active clinical trials for "Breast Neoplasms"

The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.

The aim of this study is to determine, using immunohistochemistry (IHC) on biopsies and surgically removed tumor if short-treatment immunotherapy with atezolizumab monotherapy or in combination with other biologic agents (ipatasertib / Bevacizumab / Trastuzumab / Pertuzumab) is associated with increased levels of activated GzmB+ CD8+ T cells from baseline to post treatment sample. Moreover, from baseline to post treatment sample, evolution of others biomarkers will be studied : GzmB/CD8, CD8/FoxP3, CD8/CD68 in IHC, cell proliferation, PD-L1, MHC-I, change in gene expression (RNA-Seq). Tjis study aim also to assess the safety and tolerability of study treatments in this population and to determine the effect of short-term immunotherapy treatment in pCR at surgery. Patients will undergo tumor biopsies at screening and 15 days after the beginning of treatment (if they start neoadjuvant chemotherapy) / at surgery, in order to evaluate in IHC evolution of activated GzmB+ CD8+ T cells and evaluate other markers It targets 2 different cohorts: newly diagnosed, non-metastatic early-stage triple-negative (TNBC) or HER2+ breast cancer. TNBC cohort is composed of 4 open-label, randomized arms, HER2+ of 2 arms. A maximum of 210 patients will be included in the trial (147 in TNBC cohort and 63 in HER2+ cohort). Tumor evaluation will be performed by clinical examination and Breast echography at baseline and end of treatment visit. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests and through the collection of ongoing toxicities or adverse events.

Insomnia, defined as difficulty falling asleep, staying asleep, or waking up too early at least three times a week for at least 3 months, (American Psychiatric Association 2013) is a common disorder both in the general population and in cancer patients, but it is particularly common in breast cancer patients. (Davidson JR, 2002) (Savard J, 2001). Unfortunately, this issue is often not recognized and is not adequately addressed in common clinical practice (Zhou ES, 2017). Emotional distress, stress after surgery, and side effects of cancer treatments, particularly those related to hormone therapy, all contribute to the onset of insomnia, which, in turn, can contribute to a poor quality of life, to greater fatigue in carrying out daily life activities, to worsening physical and emotional discomfort (Kyle SD, 2010) (Bolge SC, 2009) (Sarsour K, 2011). To date, insomnia in common clinical practice is an often overlooked problem. Patients report that healthcare providers rarely pay attention to sleep disorders and even if they are evaluated, treatment recommendations tend to focus primarily on prescribing medications (Siefert ML, 2014). Gemmotherapy is a young branch of phytotherapy developed in the second half of the last century. This branch bases its principles on the therapeutic potential of the meristematic tissues of plants and uses products called glycerine macerates (GM) obtained according to the method of cold maceration of meristematic tissues in water, alcohol and glycerol created by Dr. Pol Henry in the last century or according to the Pharmacopoeias. The use of concentrated GM (C-GM) has spread (Andrianne, 2008 and 2012). These C-MGs are approximately 10 times more concentrated than traditional GMs, and are therefore traditionally used at lower doses (adults: approximately 5-15 gtt/day) than those used for diluted extracts (adults: up to 1 gtt/kg/day ). Tilia tomentosa, whose fresh buds are used, is traditionally indicated in all cases of insomnia in adults and children. Its action is carried out by inducing sleep and increasing its duration. In phytotherapy it is recommended in neuroses but also as an antispasmodic, in heart palpitations and in spasmophilia. No type of acute or chronic toxicity is known for this C-GM. In the proposed study we want to evaluate the action of C-GM from Tilia tomentosa, extracted according to the Pharmacopoeias, for the treatment of insomnia in patients with breast cancer on hormone therapy.

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Zynyz™ (retifanlimab-dlwr)], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

This is a phase I open-label dose escalation trial of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer The goal of this clinical trial] is to learn about in ER+/HER2- BC participant population. The main questions it aims to answer are: Establish the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer. Explore the safety and tolerability of FWD1802 as monotherapy and in combination with Palbociclib. Characterise Pharmacokinetics of FWD1802 as monotherapy and in combination with palbociclib. Explore preliminary efficacy signals.

This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection. In consequence the data should also be taken to adapt technical features according to the findings. The study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. In the future pivotal study, the effectiveness of method and the reduction in R1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut. The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. During the second visit (V2) they will receive the treatment procedure with the investigational medical device (IMD). The follow up visit (V3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.

This is a multicenter, open-label, Phase 1/ 2 study to evaluate the short-term and longer-term safety, tolerability, and effectiveness of Immunopheresis® with the LW-02 column in removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) from plasma of patients with advanced, refractory Breast Cancer (BC) and for disease control when employed as monotherapy, or in combination with a low dose chemotherapy. A low dose chemotherapy will serve as control.

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.

This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.

Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.