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Breast Cancer clinical trials

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NCT ID: NCT05192278 Recruiting - Breast Cancer Clinical Trials

Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management

Start date: December 12, 2021
Phase: Phase 2
Study type: Interventional

Cancer breast is one of the most common tumors among women and surgery is still the key for its management and cure. Post-mastectomy pain control is crucial as acute postoperative pain is a significant factor in the development of persistent chronic pain in the form of post-mastectomy pain syndrome. Post-mastectomy pain syndrome (PMPS) is a common complication after breast cancer surgery and is often challenging to manage. It is estimated that PMPS occurs in 20%-44% of patients after breast surgery. Adequate pain control for PMPS has become one of the most important goals and recently can achieve by multiple tools including multimodal analgesia and regional techniques. Erector spinae block (ESB) is one of the new described regional techniques. Although its mechanism is not clear, the published data agree that it is promising block for chronic and acute pain and its simplicity and safety compared with thoracic epidural or bilateral paravertebral blocks. ESB can be performed using a superficial approach between the large rhomboid muscle and the erector spinae muscle or the deep method beneath the erector spinae. The use of the ESPB for chronic pain has recently expanded for various neuropathic pain conditions. Also, it reported with several volumes range from 10 to 30 ml of total volume.

NCT ID: NCT05190978 Recruiting - Breast Cancer Clinical Trials

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Start date: October 20, 2022
Phase: N/A
Study type: Interventional

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

NCT ID: NCT05190770 Recruiting - Breast Cancer Clinical Trials

A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is find out whether Oleogel-S10 is an effective treatment for radiation dermatitis when it is used in combination with a standard wound treatment cream called triamcinolone. Oleogel-S10 has shortened the healing time for other types of skin wounds such as burns. Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.

NCT ID: NCT05187338 Recruiting - Breast Cancer Clinical Trials

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Start date: November 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).

NCT ID: NCT05186545 Recruiting - Breast Cancer Clinical Trials

An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, single center, single arm phase II study designed to explore the efficacy and safety of surufatinib + fulvastrant + chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy.

NCT ID: NCT05184582 Recruiting - Breast Cancer Clinical Trials

Physical Exercise During Preoperative Chemotherapy for Breast Cancer

Neo-ACT
Start date: November 9, 2022
Phase: N/A
Study type: Interventional

Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes. The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses. 712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.

NCT ID: NCT05183126 Recruiting - Breast Cancer Clinical Trials

Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Breast Cancer

Start date: March 28, 2022
Phase: Phase 4
Study type: Interventional

The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.

NCT ID: NCT05181722 Recruiting - Breast Cancer Clinical Trials

Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

NCT ID: NCT05181033 Recruiting - Breast Cancer Clinical Trials

Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor

Start date: December 27, 2021
Phase: Phase 2
Study type: Interventional

Based on the results of the phase Ib/II study, the investigators hypothesize that combining a RET inhibitor lenvatinib with endocrine therapy letrozole improves objective response and progression-free survival compared to fulvestrant alone in the second line setting in patients who have progressed on first line endocrine therapy incorporating a CDK4/6 inhibitor. Letrozole and fulvestrant are anti-hormonal drugs that have been proven to have activity and are considered standard therapies for hormone receptor positive breast cancer. The purpose of this study is to determine if the combination therapy of letrozole (an anti-hormonal drug) and lenvatinib (a targeted therapy), when compared to another anti-hormonal drug fulvestrant, is effective in patients with hormone receptor positive breast cancer. Preliminary studies have shown that approximately 50-60% of hormone receptor positive breast cancers over-express RET, and may therefore respond to treatment by a drug that blocks the RET pathway. An earlier study conducted at the National University Cancer Institute, Singapore (NCIS) on the combination of letrozole and Lenvatinib has shown promising results. Among patients in whom hormonal therapy and a CDK4/6 inhibitor no longer worked, about one-quarter of patients had meaningful disease control. The study also showed that patients tolerated the combination of Lenvatinib and letrozole well with manageable side effects. Based on the promising findings from the earlier study, this study seeks to compare the effectiveness of lenvatinib plus letrozole with another standard anti-hormone treatment drug called fulvestrant. In addition, investigators are studying how body reacts to the treatment as well as studying gene and protein changes in the tumour in response to treatment, which may in the future, help us tailor drug treatment for individual patients according to the patient's and/or the tumour's genetic or protein make-up.

NCT ID: NCT05180851 Recruiting - Breast Cancer Clinical Trials

Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study

YSCH-01
Start date: November 30, 2021
Phase: Early Phase 1
Study type: Interventional

This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection(YSCH-01) when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection