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Breast Neoplasms clinical trials

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NCT ID: NCT06266312 Not yet recruiting - Breast Cancer Clinical Trials

Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer

APRIORI
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.

NCT ID: NCT06265558 Not yet recruiting - Breast Cancer Clinical Trials

Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery

TPN-SEIN
Start date: September 2024
Phase: N/A
Study type: Interventional

There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction. That strategy of treatment-reconstruction has expanded increasingly since the last years. The current literature reports only 3 studies on the use of preventive negative pressure therapy in oncologic breast surgery. Moreover, all three are retrospective, case-control studies with serious limitations. The largest published series reports a reduction in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of comorbidities, surgical procedure performed, inclusion periods (and therefore experience in performing oncological surgery). There was also a high probability of under-assessment or postponement of post-operative complications, which is typical of published retrospective surgical studies. The published results therefore strongly encourage further investigation of negative pressure therapy in oncological breast surgery.

NCT ID: NCT06265077 Not yet recruiting - Breast Cancer Clinical Trials

Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients

Start date: February 2024
Phase: Phase 1/Phase 2
Study type: Interventional

No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.

NCT ID: NCT06260033 Not yet recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

Start date: June 11, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment. This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.

NCT ID: NCT06259929 Not yet recruiting - Breast Cancer Clinical Trials

NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer

Neo-AGILE
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: - To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 - To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response; - To evaluate the safety of abemaciclib and giredestrant. Exploratory objectives: - To evaluate the mechanisms of response and resistance to therapy; - To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction; - To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

NCT ID: NCT06257888 Not yet recruiting - Clinical trials for Breast Neoplasm Malignant Primary

A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients

NAVIMOZ
Start date: February 2024
Phase:
Study type: Observational

The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows: - Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment? - Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.

NCT ID: NCT06255392 Not yet recruiting - Breast Cancer Clinical Trials

Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

Start date: February 2024
Phase: Phase 3
Study type: Interventional

This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets. The trial aims at extending the combination target therapy involving PARP inhibitors and anti-angiogenesis from only BRCA mutation carriers to all patients with homologous recombination repair defects (HRD-positive). The phase III randomized clinical study will investigate the effectiveness of the combination therapy of PARP inhibitor "fludzoparib" and anti-angiogenic "apatinib" in treating HRD-positive/HER2-negative advanced breast cancers.

NCT ID: NCT06254066 Not yet recruiting - Clinical trials for Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer

Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer

Start date: April 16, 2024
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm, exploratory study planned to include 40 patients with HRD-positive HR +/HER2- advanced breast cancer treated with Adebrelimab in combination with fluzoparib. To observe and evaluate the efficacy and safety of Adebrelimab combined with fluzoparib in the treatment of HRD-positive HR +/HER2-advanced breast cancer

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: January 2025
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: NCT06247995 Not yet recruiting - Breast Cancer Clinical Trials

A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

Start date: May 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).