Active clinical trials for "Breast Neoplasms"

The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.

Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.

This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole. This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.

An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.

This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab may increase the effect of balstilimab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).

Extracorporeal Shock Wave Therapy (ESWT); It is a treatment method in which high-intensity pressure waves are applied to the desired point in the body. It has been used in the treatment of kidney stones in previous years, and changes in bone tissue have been observed . Today, it is used in musculoskeletal diseases such as plantar fasciitis, epicondylitis, achillestendinitis, and osteoarthritis. The main mechanism of action of ESWT is not clearly known, but many studies have shown that it stimulates the early release of angiogenesis-related growth factors such as endothelial nitric oxide synthase (eNOS) and vascular endothelial growth factor (VEGF) and increases blood circulation with induced neovascularization, resulting in cell proliferation and tissue growth. It has been shown to increase regeneration . It has been found to be effective in lymphedema with neovascularization and lymphatic channel synthesis . In the literature, there are studies investigating the additional contributions of complex decongestive therapy combined with ESWT in patients with lymphedema.

This is an open label, lead in phase Ib dose confirmation study in patients with advanced solid tumors, followed by a phase II single arm study as neoadjuvant therapy in stage I-III HER2 negative breast cancer. Primary Objectives To determine the safety profile of combination of ADG106 with dose dense doxorubicin/cyclophosphamide, and with weekly paclitaxel. To determine the Recommended Phase 2 Dose (RP2D) of ADG106 in combination with dose dense doxorubicin/cyclophosphamide, and with weekly paclitaxel. To evaluate biological changes on immunohistochemistry in HER2 negative breast cancer after treatment with ADG106 alone and in combination with chemotherapy. Secondary Objectives To determine the efficacy of combination of ADG106 with standard neoadjuvant combination chemotherapy in HER2 negative breast cancer: objective response rates. To correlate tumor and plasma biomarkers with efficacy outcomes.

This is an open label, non randomised, investigator-initiated Phase II study of single agent talazoparib (Talzenna®) in metastatic triple negative breast cancer patients with enriched HRD signature. Approximately 55 subjects will be enrolled in this study to examine the efficacy of talazoparib when given orally 1mg daily for days 1 to 28 for up to 28 months. The study will be conducted using the Simon two-stage phase II design, whereby this study will initially enroll 19 patients with RECIST v1.1 measurable disease with enriched HRD signature (stage I). There will be one interim analysis at the end of stage I and if 3 of the 19 have a response, then no further patient will be accrued. If 4 or more of the 19 patients have a response, then accrual would continue to stage II until a total of 55 patients have been enrolled. This study will be conducted in conformance with Good Clinical Practices. Specific procedures to be performed during the trial, as well as their prescribed times and associated visit windows, are outlined in the Trial Flow Chart.

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.