Active clinical trials for "Breast Neoplasms"

Triple-negative breast cancer (TNBC) is a group of tumors that occurs mainly in young, premenopausal women and accounts for 10-20% of breast cancers. Over the past decade, the incidence of women diagnosed with early-stage TNBC has significantly increased due to the widespread use of screening mammography. Treatment of patients with localized TNBC mainly involves surgery and (neo)adjuvant chemotherapy with or without radiotherapy. However, the benefit of chemotherapy may be controversial in patients with early-stage TNBC defined by small size and absence of lymph node involvement, and with significant tumor lymphocyte infiltration. The ETNA study is a phase II trial designed to evaluate a chemotherapy de-escalation strategy in patients with TNBC T1b/c N0M0 and stromal TILs (sTILs) ≥ 30%. ETNA comprises two cohorts defined according to the level of TILs and the age of patients. Patients aged > 40 years with 30% ≤ sTILs < 50% and those aged ≤ 40 years with 30% ≤ sTILs < 75% will be included in the cohort 1 and will receive adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles. Patients aged > 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% will be included in cohort 2 and will not receive adjuvant treatment, they will undergo standard surveillance every six months.

TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size >5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.

This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy. The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to: Experimental group: JSKN003 monotherapy Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

This is a proof-of-concept, single-center, non-randomized, open-label, phase 1b/2 study to evaluate the safety and efficacy of ConvitVax, a simple, low cost (of manufacture), personalized, potentially safe and effective breast cancer vaccine made of three components: autologous tumor cells homogenate obtained from 0.3 g of tumor tissue, 0.0625 mg of bacillus Calmette-Guérin Danish strain 1331 (BCG D1331), and 0.02% of formalin, for patients with metastatic breast cancer (MBC) except for brain metastases, leptomeningeal carcinomatosis, and/or spinal cord compression. The primary aim is to determine the overall safety and tolerability of ConvitVax when administered via an intradermal (id) injection as monotherapy in female patients with MBC who have failed at least one line of therapy. This study will give access to an immunotherapy, to underprivileged women with MBC, particularly in poor developing countries where patients may not have the opportunity to be treated with modern therapies or, in many cases, standard of care treatments. Breast cancer patients at Instituto de Oncología "Dr. Luis Razetti" (Oncological Institute "Dr. Luis Razetti") (IOLR) who meet the eligibility criteria will be consented and asked to have a biopsy of the primary tumor. This fragment will be divided for the preparation of each dose of the vaccine. A total of 40 patients with confirmed MBC will be treated with ConvitVax. The final volume per dose of the vaccine is 0.5 ml, with a total of 4 doses. ConvitVax will be applied via id injection with a 2-week interval between each dose. Patients will be monitored for disease recurrence and survival, for a period of 1 year after initiating the treatment.

this study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy will be compared to the effect of traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.

Obesity could become the first evitable cause of breast cancer in the near future. Due to the relatively slow rate of development in this field, greater efforts must be applied in this area. The HYPOTHESIS of this work is that "a therapy to lose weight in breast cancer women with obesity during the oncological treatment could contribute to slowing carcinogenesis, and to improve the response to the chemotherapy, survival and prevent future recurrences by erasing deleterious epigenetic marks". A group of breast cancer women with obesity (n=90) will be treated to lose weight during the oncologic treatment with a low calorie-ketogenic diet or a group educational intervention program of healthy lifestyle. The reversibility of the obesity-related breast cancer epigenetic signatures (EPIC array and pyrosequencing) and other molecular features (QRTPCR, ELISA assays) in blood leukocytes and plasma and the progression of disease will be compared with an obesity (n=30) and normalweight (n=30) group under conventional anticancer therapy. A matched-group of tumor-free women (n=60) with obesity will be also treated to lose weight with the same nutritional interventions and compared with tumor-free women with normal weight (n=30) in order to evaluate the potential preventive function of weight loss therapies on cancer-related odds. The outcomes of this project will directly benefit overweight and obese patients from healthcare systems, and also to have an economic value supporting pharmaceutical and food industry companies in the design of innovative treatments, useful biomarkers and preventive tools.

The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are: Evaluate the sensitivity and specificity of the early detection model for breast cancer screening Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library. Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.

(Neo)adjuvant treatment approaches and outcomes

To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.