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Breast Cancer clinical trials

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NCT ID: NCT05826964 Recruiting - Breast Cancer Clinical Trials

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC). Currently frontline therapy for pts with HR+ ABC is antihormonal therapy with an aromatase inhibitor or selective estrogen receptor degrader plus a CDK4/6i. The proposed trial is a randomized study to further evaluate the potential benefit of switching a frontline regimen at the time that a molecular signal, ctDNA, suggests progression prior to detection of clinical progression using standard methods. The purpose of this study is to determine whether switching treatment earlier in the disease process, based on molecular progression, will increase the amount of time that a patient's metastatic breast cancer is controlled compared to patients with metastatic breast cancer who receive treatment later based on diagnostic imaging results or other methods currently used in medical practice.

NCT ID: NCT05825768 Recruiting - Breast Cancer Clinical Trials

Preoperative Magnetic Resonance Imaging to Obtain Adequate Resection Margins in Breast Conserving Surgery, (PRIMAR) Trial

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

The goal of this randomised study is to investigate if a supplementary preoperative breast Magnetic Resonance Imaging (MRI) improves the assessment of breast cancer and can help surgical planning such that sufficient resection margins can be obtained during breast conserving surgery. The main questions are: 1. Is preoperative breast MRI in addition to the currently used standard imaging methods ultrasound and mammography more accurate to detect Ductal Carcinoma in Situ and the invasive breast tumor compared to standard methods only? 2. Does preoperative breast MRI reduce the number of involved histological margins after breast conserving surgery in the MRI-group versus the control group?

NCT ID: NCT05825547 Recruiting - Breast Cancer Clinical Trials

Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy

CRIMCAS
Start date: February 16, 2022
Phase: N/A
Study type: Interventional

Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines. In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy. The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.

NCT ID: NCT05825482 Recruiting - Breast Cancer Clinical Trials

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

NCT ID: NCT05823623 Recruiting - Breast Cancer Clinical Trials

Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer

Start date: February 13, 2022
Phase: Phase 2
Study type: Interventional

In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on trastuzumab.

NCT ID: NCT05823467 Recruiting - Breast Cancer Clinical Trials

What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery

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

This study will look at whether females who have previously had breast surgery and radiation and are undergoing repeat breast surgery require any post operative interventions. The reason the investigators are conducting this study is because females who have undergone breast radiation are at higher risk of wound complications following breast surgery. The investigators will randomize recruited female participants into three arms, one which is post operative antibiotics for one week, one which is a wound VAC, and one which is no intervention. The investigators goal is to identify whether these patients will require any postoperative interventions.

NCT ID: NCT05821244 Recruiting - Breast Cancer Clinical Trials

Exercise Timing in Breast Cancer Patients

Start date: July 5, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the feasibility of assigning breast cancer survivors currently receiving chemotherapy to exercise at a specific time of day, e.g., morning or afternoon/evening, for a 4-week exercise intervention. Information gathered from this study will help inform a future, larger trial. Study Aims: 1. Assess the feasibility of engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Assigning windows of time within the day to complete exercise (e.g. 5-10am exercise start time vs. 3-8pm exercise start time) will be feasible among this patient population. 1a. Determine the acceptability engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Engaging in exercise at an assigned time-of-day will be acceptable in this patient population. 2. To generate evidence on the magnitude of the effect sizes and outcome variability of physical function and human performance variables. Tests to be conducted at baseline and end of study to measure physical function and human performance variables include: Timed up and go test, 30-second chair stand, handgrip strength, cardiorespiratory fitness.

NCT ID: NCT05817227 Recruiting - Breast Cancer Clinical Trials

Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

Selebrec
Start date: May 19, 2022
Phase:
Study type: Observational

This is multicentric, spontaneous, observational, retrospective and prospective study.

NCT ID: NCT05817175 Recruiting - Breast Cancer Clinical Trials

International Prospective REgistry on Pre-pectorAl Breast REconstruction

I-PREPARE
Start date: October 16, 2023
Phase:
Study type: Observational

This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.

NCT ID: NCT05814354 Recruiting - Breast Cancer Clinical Trials

SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

Start date: June 30, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.