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Breast Neoplasms clinical trials

View clinical trials related to Breast Neoplasms.

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NCT ID: NCT06131424 Not yet recruiting - HER2-negative Clinical Trials

NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients

iRetroBC
Start date: March 4, 2024
Phase:
Study type: Observational

This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2 -(HER2)low locally-advanced or metastatic breast cancer(mBC) by accurate rescoring of archived IHC-stained formalin-fixed paraffin-embedded (FFPE) slides for HER2 in patients previously identified as HER2-negative from emerging markets of international regions (non-US and non-European region) with largely unknown prevalence estimates of HER2 low mBCs. Patients with a confirmed diagnosis of HER2-negative, locally-advanced or mBC regardless of Hormone receptor (HR)status between 01 January 2019 and 31 December 2022 who progressed on any systematic anticancer therapy (eg, ET, chemotherapy, CDK4/6 inhibitor, targeted therapies other than anti-HER2, or immunotherapy) in advanced disease with availability of atleast 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis of locally-advanced or mBC will be enrolled in the study. The HR positive patients will be considered eligible for the study if they have received ET as adjuvant therapy in the early BC setting and progressed within 24 months. This scenario will be considered as progression on systematic treatment in the advanced or metastatic setting.

NCT ID: NCT06130826 Not yet recruiting - Breast Carcinoma Clinical Trials

Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer

Start date: June 12, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT) and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen (CEA) positive breast cancer that cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Carcinoembryonic Antigen (CEA) is a protein that is present in most colorectal cancers and in many other cancers, such as breast cancer, as well. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Cytokines are signaling proteins that help control inflammation in the body. They allow the immune system to mount a defense if germs or cancer or other substances that can make people sick enter the body. Interleukin-2 (IL-2) is a powerful cytokine able to regulate the immune responses that are important for anticancer immunity. Immunocytokines (also called antibody-cytokine fusion proteins) are small proteins that regulate the activity of immune cells. The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2. Giving M5A-ICK in combination with standard of care (SOC) SBRT may work better in treating patients with unresectable metastatic colorectal cancer or CEA positive metastatic breast cancer.

NCT ID: NCT06126640 Not yet recruiting - Clinical trials for HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy

A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy

Start date: November 2023
Phase: Phase 3
Study type: Interventional

This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy,This study will examine SHR-A1811versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes after neoadjuvant therapy.The primary objective is to compare invasive disease-free survival (IDFS) between SHR-A1811 and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS), overall survival (OS) and distant recurrence-free interval (DRFI).

NCT ID: NCT06123988 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

FastER
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor.

NCT ID: NCT06123819 Not yet recruiting - Breast Cancer Clinical Trials

Shear-wave Elastography in Breast Cancer

Start date: November 2023
Phase:
Study type: Observational

The purpose of this study is to determine the relationship of the SWE elastic modulus and the molecular types of breast cancer .

NCT ID: NCT06113627 Not yet recruiting - Survivorship Clinical Trials

Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

LinfoGYM
Start date: August 2024
Phase: N/A
Study type: Interventional

The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.

NCT ID: NCT06111417 Not yet recruiting - Breast Cancer Clinical Trials

Use of an Ultra-rapid BRCA1/2 Status Screening Test in Theranostic Indication: Performance and Interest for Patients and Practitioners

TURBO
Start date: April 1, 2024
Phase:
Study type: Observational

The time taken to obtain the results of germline mutations in BRCA1 and BRCA2 has become a major issue in adapting the therapeutic management of patients, particularly those with breast cancer. The time taken to obtain the results of BRCA1/2 tests in routine laboratories with a view to personalised treatment can range from a few weeks to a few months. The waiting time required to obtain results is likely to cause stress and anxiety in cancer patients. The investigators hypothesise that ultra-rapid testing can reduce anxiety about patients' genetic status and improve their mental well-being. The main objective of this project is to compare the results obtained with an ultra-fast kit developed by O.N.T with those obtained with the current gold standard, NGS sequencing.

NCT ID: NCT06110845 Not yet recruiting - Breast Cancer Clinical Trials

CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)

CLEOPATRAA
Start date: December 1, 2023
Phase:
Study type: Observational

The goal of this non-interventionist observational study is to test the performance of a computer algorithm (QPORB) which examines breast cancer biopsy digital images to provide diagnostic support. The main question[s] it aims to answer are: 1. The principal research aim is to determine whether 4D Path's Technology Q-Plasia OncoReader Breast, that has been developed in the research setting, works robustly in the clinical environment (i.e. to define its real-life clinical utility) in terms of breast carcinoma grading and molecular subtyping 2. The secondary research aim is to perform an economic analysis alongside the trial in order to establish the time, resource and cost savings that the technology could afford the NHS, the ideal price point for engaging with the technology and the cost:benefit ratio for evaluation by the National Institute for Clinical Excellence 3. The tertiary research aim is to gather long-term follow-up data to better understand long-term response to therapy and prognosis and potential future uses of the algorithm Participants's specimens will be tested alongside routine clinical workflows without intervention or consent. Researchers will compare the algorithm's results to those of routine diagnostic standard of care workflows.

NCT ID: NCT06107894 Not yet recruiting - Clinical trials for Advanced Breast Cancer

TIL Therapy for Patients With Advanced Solid Tumors

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

This study is a phase I clinical trial to investigate the safety and tolerability of NEOG-100 in patients with advanced breast cancer and lung cancer. NEOG-100, an autologous tumor infiltrating lymphocytes (TILs), is infused intravenously into the patient after non-myeloablative (NMA) lymphodepletion treatment.

NCT ID: NCT06106711 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).

EVA
Start date: November 2, 2023
Phase:
Study type: Observational

The study stems from the need to detect adverse events arising after the administration of Antibody-Drug Conjugates (ADCs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.