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Breast Neoplasms clinical trials

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NCT ID: NCT06028022 Recruiting - Clinical trials for Estrogen Receptor-Positive Breast Carcinoma

Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors

Start date: October 18, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and lessen fatigue. Reishi mushroom extracts have not been studied explicitly for treatment-induced arthralgias/myalgias, but have been shown to improve quality of life, muscular strength, pain, and flexibility. Information from this study may help researchers determine the effect of Reishi mushroom extract on fatigue and arthralgias/myalgias in breast cancer patients receiving an AI.

NCT ID: NCT06027268 Recruiting - Clinical trials for Metastatic Triple-Negative Breast Cancer

Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

ToPCourT
Start date: January 10, 2024
Phase: Phase 2
Study type: Interventional

The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative breast cancer. The main questions it aims to answer are: - to evaluate the anti-cancer efficacy (assess how well it works) - to evaluate the safety and tolerability (how well the body can handle the treatment) of this combination of anti-cancer therapy

NCT ID: NCT06026657 Recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer

Start date: March 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial tests the safety, best dose and how well gemcitabine and ex vivo expanded allogenic universal donor TGFBi NK cells with or without naxitamab work for the treatment of patients with GD2 expressing, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. TGFBi NK cells are manufactured cells that are a part of your natural immunity. NK cells can recognize missing or incorrect proteins on tumor cells and then eliminate these tumor cells and TGFBi NK cells are created to be able to better kill the tumor cells. Naxitamab is a monoclonal antibody that targets GD2, which is a protein or sugar present on tumor cells but not very commonly found on normal cells. This antibody helps draw the attention of the immune system to the tumor cells that have GD2 to help attack the tumor cells. Giving gemcitabine and TGFBi NK cells with or without naxitamab may kill more tumor cells in patients with metastatic GD2 expressing, HER2 negative breast cancer.

NCT ID: NCT06025604 Recruiting - Clinical trials for Breast Cancer Female

ACTIVPROSEIN : Professional Activity After Breast Cancer

Start date: September 14, 2023
Phase:
Study type: Observational

Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity. Those observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery. The objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment). To identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients. The main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)

NCT ID: NCT06024187 Recruiting - Breast Neoplasms Clinical Trials

Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery. The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.

NCT ID: NCT06023576 Recruiting - Breast Cancer Clinical Trials

A Study of Blood Pressure Control During Cancer Treatment

Start date: August 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer. The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.

NCT ID: NCT06020573 Recruiting - Breast Cancer Clinical Trials

Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection

Start date: September 26, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06019988 Recruiting - Breast Cancer Clinical Trials

Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer

Breast_SBDOH
Start date: March 11, 2024
Phase: N/A
Study type: Interventional

The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with a pathological diagnosis of breast cancer at Penn Medicine. The investigators will measure rates of SBDOH data collection by modality and rates of referral to and uptake of social support services, time to evaluation, staff time, acceptability, patient-centered communication, medical mistrust, and clinician acceptability.

NCT ID: NCT06018337 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry [IHC]2+/in situ hybridization [ISH]- and IHC 1+) population.

NCT ID: NCT06016790 Recruiting - Breast Cancer Clinical Trials

Exploring a Breast Cancer Early Screening Model Based on cfDNA

Start date: May 3, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are: - Evaluate the sensitivity and specificity of the early detection model for breast cancer screening - Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library. Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.