Active clinical trials for "Breast Neoplasms"

The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer. In this phase III, multi-center, open-label, randomized controlled study, 552 subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Utidelone plus AC group or the docetaxel plus AC group, stratified by hormone receptor status (ER and/or PgR positive vs ER and PgR negative).

The purpose of this trial is to establish a feasible DVH estimation model of integrated IMRT plan for HF-RNI with Eclipse™ Treatment Planning System and a Varian RapidPlan™ model based on the above DVH constraints.

The study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in Poland in the real-world data setting. The main goals are to assess the current treatment patterns of hormone receptor-positive (HR+) Human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer and their changes in clinical practice and relate them to patients' demographics, disease characteristics, type of other therapies used in patients as well as disease progression and visceral crisis occurrence.

The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of IVIM functional parameters and DCE-MRI parameters in predicting the efficacy.To explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. And to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis. At the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.

Adjuvant treatment with tamoxifen is the standard of care for women with estrogen receptor positive (ER+) breast cancer. Tamoxifen is converted to endoxifen, its active metabolite, via CYP2D6 enzymes. The literature states that an endoxifen concentration of at least 16 nmol/L is needed to produce a therapeutic effect (4). Therapeutic Drug Monitoring (TDM) has been proven to be a successful technique to reach the 16 nmol/L endoxifen threshold after 6 months. However, in general TDM can only be used when a drug is in steady-state, which for endoxifen is reached after 3 months for normal metabolizers. For poor- and intermediate metabolizers, the time until steady-state is presumably even longer. This could possibly result in undertreatment within the first 3 to 6 months of tamoxifen treatment. In this study, model-informed precision dosing (MIPD) will be used to counter this problem. The Pharmacokinetic-model, which is used for MIPD, includes CYP2D6 genotype, co-medication, age, body height, BMI and CYP2D6/CYP3A inhibitor use to predict a patient tailored dose. Using MIPD, our aim is to decrease the proportion of patients that are undertreated within the first three months of tamoxifen treatment.

This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic breast cancer (BC) and in patients with documented HER2-low unresectable or metastatic BC receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).

Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.

The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.

During COVID-19, telecare replaces face-to-face contact to maintain social distance and reduce the spread of the virus. The current epidemic is coming to the end. However, for breast cancer cases, no matter in the treatment or survival stage, they face physical and mental symptoms, such as "social isolation", which affects their quality of life. Studies have shown that mindfulness and dance can help breast cancer cases improve depression and quality of life, but most of them are conducted face-to-face. Online mindful/dance helped breast cancer cases without the limitations of the time, space, distance, and treatment status, but lacking enough evidence. The purpose of this study will to design a "home based digital mindful dance program" suitable for our breast cancer cases, and conduct clinical trial on its feasibility, mind and body awareness, and quality of life. Finally, through in-depth interviews, we will understand the subjective experience of breast cancer cases on the program. The research results are expected to provide an empirical reference for multi-care for breast cancer to our country and abroad.

This is a single-center, prospective pilot study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatment (RT) for breast cancer.