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Breast Cancer clinical trials

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NCT ID: NCT06268665 Not yet recruiting - Breast Cancer Clinical Trials

Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

Start date: February 28, 2024
Phase: Phase 2
Study type: Interventional

This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy. Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).

NCT ID: NCT06268327 Not yet recruiting - Breast Cancer Clinical Trials

Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy

Start date: April 30, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine

NCT ID: NCT06267014 Not yet recruiting - Breast Cancer Clinical Trials

Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity

Cog-RV
Start date: March 2024
Phase: N/A
Study type: Interventional

The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation. Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.

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: 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: 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: NCT06252662 Not yet recruiting - Breast Cancer Clinical Trials

Liposomal Bupivacaine vs Bupivacaine With Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies

Start date: April 2024
Phase: Phase 4
Study type: Interventional

Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.

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.