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Breast Tumor clinical trials

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NCT ID: NCT06251544 Not yet recruiting - Breast Cancer Clinical Trials

TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer

Start date: March 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing breast cancer. Patients eligible for this study have metastatic breast cancer that has HER2 expression and has progressed on at least one line of therapy. This is a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body recognize and fight cancer cells. The body has different ways of fighting diseases and no single way seems perfect for fighting cancer. This research combines two different ways of fighting cancer: antibodies and T cells. Antibodies are proteins that protect the body from infectious disease and possibly cancer. T cells, or T lymphocytes, are special blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have shown promise treating cancer but have not been strong enough to cure most patients. Previous research has found that investigators can put genes into T cells that helps them recognize cancer cells and kill them. Investigators now want to see if by putting a new gene in those T cells to help recognize breast cancer cells expressing HER2 can kill the cancer cells. In clinical trials for various cancer types that express HER2, our center engineered a CAR that recognizes HER2 and put this CAR into patients own T cells and gave them back. Investigators saw that the cells did grow and patients did tolerate and respond to the treatment. Investigators will add a gene to the HER2 recognizing CAR T cells that will improve the T cells function. Investigators know that some immune cells in the body can lower T cells ability to kill cancer cells. Investigators have identified an antibody that will inactivate those immune suppressive cells thereby allowing T cells to survive better to recognize and kill cancer cells. This antibody targets the Trail-R2 receptor and is referred to as TR2. Also, investigators know that T cells need the support of cytokines to perform their immune functions. There is evidence showing that the addition of interleukin 15 (IL15) enhances CAR T cells ability to kill cancer cells. As a result, investigators also added IL15 to the HER2 and TR2 targeting CAR T cells (HTR2 T cells). The HTR2 T cells are an investigational product not approved by the Food and Drug Administration.

NCT ID: NCT06172270 Recruiting - Breast Tumor Clinical Trials

Sub-regional Tumor Segmentation Based on CEUS Perfusion Characteristics: Enhancing Breast Tumor Diagnosis

Start date: July 1, 2023
Study type: Observational

The goal of this study is to investigate breast cancer's internal heterogeneity and enhance diagnostic accuracy. We aim to achieve this by utilizing Contrast-Enhanced Ultrasound (CEUS) technology, which provides detailed information about tumor perfusion dynamics. Traditional biopsy methods have limitations due to the invasive nature and complexity of breast cancer heterogeneity. Participants in this study will undergo preoperative breast cancer diagnosis using CEUS technology, which is safe, cost-effective, and convenient. Dynamic CEUS videos will be used to cluster perfusion characteristics at the pixel level within breast tumors, allowing us to divide the tumors into distinct subregions based on these clusters. We will then explore the correlation between these perfusion subregions and the diagnosis of benign or malignant breast tumors. Our ultimate aim is to develop diagnostic models that utilize non-invasive imaging data to enhance breast cancer diagnosis. This approach reduces subjective judgments in the diagnostic process, potentially improving diagnostic accuracy. It also provides valuable information for personalized treatment decisions, thus advancing the field of breast cancer treatment.

NCT ID: NCT05544123 Recruiting - Breast Cancer Clinical Trials

The Treatment Situation of Chinese County Population With Breast Cancer

Start date: September 29, 2022
Study type: Observational

The study is a multi-center, non-interventional, prospective observational study which enrols 2500 breast cancer patients from China county area. The purpose of this study is to be aware of the real-world data of the current breast cancer diagnosis and treatment model in the county. It aims to understand the gap between the county and the SOC in the diagnosis and treatment.

NCT ID: NCT05389605 Completed - Breast Cancer Clinical Trials

Outcomes of Local Perforator Flaps in Oncoplastic Surgery

Start date: April 18, 2020
Study type: Observational

This is a single center experience of using local perforator flaps in partial breast reconstruction for breast tumors while evaluating cosmetic outcomes, patient satisfaction and well-being using a validated self-administered questionnaire.

NCT ID: NCT05252390 Recruiting - Breast Cancer Clinical Trials

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Start date: March 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

NCT ID: NCT05191004 Withdrawn - Breast Cancer Clinical Trials

Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

Start date: September 2022
Phase: Phase 1/Phase 2
Study type: Interventional

NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

NCT ID: NCT05185752 Completed - Postoperative Pain Clinical Trials

Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The present study compares the Erector Spinae Plane (ESP) block, Pectoral (PECS II) block, and Serratus-Intercostal Fascial Plane (SIFP) block. This is the first article to compare these three locoregional nerve block techniques in acute and chronic postoperative pain in breast tumour surgery. From June 1, 2018, to June 30, 2019, 103 patients undergoing breast cancer surgery were randomised to undergo one of three locoregional techniques (35 for ESP block, 34 for PECS II block, 34 for SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast cancer surgery. Outcomes measured included pain (visual analog scale [VAS] in immediate postoperatory and at 24 hours. It also was collected opioid use at 24 hours, adverse events, and length of stay (for acute postoperatory). Moreover, at 3 months, a telephone interview was conducted with the patient and VAS was questioned. A year later, the patient was questioned again and asked for VAS, location of her pain, and pharmacological treatment. It was collected if patients were assisted or not by a Pain Unit.

NCT ID: NCT05169437 Active, not recruiting - Pancreatic Cancer Clinical Trials

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Start date: March 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.

NCT ID: NCT04948983 Recruiting - Breast Cancer Clinical Trials

The Effect of a Patient Decision Aids for Breast Cancer Screening

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Breast cancer is one of the most common cancers in Chile. National efforts focus on early detection, offering universal access to breast cancer screening through mammography to women at risk age. However, 30% of women do not undertake the exam due to a lack of knowledge and anxiety when facing the decision. The aim of this study is to develop and evaluate the effectiveness of a decision aid (DA) for women facing breast cancer screening decision in the country. Methods: following the Medical Research Council guidelines for the development and implementation of a complex intervention in public health, the investigators have: 1) culturally adapted the German DA for mammography; 2) conducted focus groups with experts to further develop the DA; 3) pilot-tested the online DA with 20 women in primary care centres. A total of 3,269 women aged 50 to 69 years old are invited to join the study. The intervention group accesses a webpage, answers a set of questionnaires at baseline, and then the DA (developed according to the IPDAS recommendations). The Control group accesses a webpage, answers a set of questionnaires at baseline, and then receives standardised information given by the healthcare system. Both groups complete the questionnaires two weeks later. The primary outcome measure is an adapted and validated version of Informed Choice. Additionally, decisional conflict, anxiety, and screening undertake rate are measured. Multiple lineal regression analysis will be conducted.

NCT ID: NCT04852926 Recruiting - Breast Cancer Clinical Trials

Study of the Sexual Health of Patients Treated for Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital.

Start date: July 13, 2021
Study type: Observational

Study of sexual health by repeated anonymous self-administered questionnaires in patients treated for non-metastatic breast cancer and referred to Jeanne de Flandre hospital for possible preservation of their fertility. Sexual health is affected by treatments and improves after the treatments. Sexual health is influenced by multiple factors : oncology treatments received, self-esteem, body image, anxiety, depression, professional activity