Serratus Anterior Plane Block for Modified Radical Mastectomy: Double-point VS Single-point
Mammary CancerSerratus Anterior Plane Block1 moreNowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery. As is known to all, less postoperative complications and enhanced recovery are closely related to effective analgesia. However, postoperative patients often experience moderate pain, while associated with axillary discomfort. Serratus Anterior Plane Block (SAPB) relieves postoperative pain, but traditional single point block method has no effect on axillary discomfort. Therefore, it is necessary to try double point blocks to explore their impact on postoperative analgesia and axillary comfort. This RCT will recruit patients proposed to undergo Modified Radical Mastectomy (MRM) and be randomized to single point or double point groups to evaluate their postoperative pain score and axillary comfort in order to provide clinical guidance.
Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity...
Breast Neoplasm FemaleNeoplasm Metastasis1 moreThe research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the established inclusion criteria. With this study, it is pretend to demonstrate the benefits of a program of therapeutic exercise and functional recovery of motor control with ultrasound feedback for the improvement of the functional capacity of the women eligible to participate in the study, as well as a positive impact on the quality of life of the patients other than their survival. The effect of the Overcome program will be compared with the usual treatment in this type of pathology. To do this, a pre-intervention evaluation and another at the end of the evaluation of the variables to be measured, such as functional capacity, will be carried out. In addition other evaluation will be carried out, after 6 months to assess the long-term effects. In addition to the three main variables such as functional capacity and quality of life, another relationship of secondary variables will be studied, such as physical state, body composition or pain threshold, among others. This study in its entirety will be carried out by the "Oncology Patient Support Unit - Take Care" in the hands of a multidisciplinary team, carrying out the intervention protocolized by physiotherapists and occupational therapists.
(VELA) Study of BLU-222 in Advanced Solid Tumors
Advanced Solid TumorsHR+ Breast Cancer7 moreThis is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo...
Breast NeoplasmsThe primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant. The primary scientific question of interest is: what is the treatment effect based on PFS for alpelisib in combination with fulvestrant versus placebo in combination with fulvestrant in Chinese men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who received prior treatment with an aromatase inhibitor (AI) either as (neo) adjuvant treatment or as treatment for advanced disease, regardless of study treatment discontinuation or start of new anti-neoplastic therapy.
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast...
Breast CancerThe effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8Invasive Breast Carcinoma2 moreThis phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid [DNA]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic...
Breast CancerAntibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits. Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies. Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms.
Breast Mesh Used in Two-staged Breast Reconstruction
Breast CancerRadiation2 moreThis is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.
Efficacy and Safety of Combinition of Camrelizumab in Second-line Neoadjuvant Chemotherapy and Adjuvant...
HER2-negative Breast CancerNeoadjuvant Therapy4 moreThe achievement of pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) is associated with improved outcome across all breast cancer (BC) subtypes. Anthracycline and taxanes based chemotherapy is usually the first choice of NACT for human epidermal growth factor receptor 2 (HER2) negative breast cancer, but there is no ideal second-line therapy for those with unsatisfactory effect after first-line NACT. Vinorelbine combined with cisplatin may be a choice for patients after failure or progression with anthracycline and/or taxanes. Immunotherapy has achieved good efficacy in many malignant tumors. Chemotherapy may have a certain immune activation effect, thus combination of immunotherapy and chemotherapy has significant clinical value in neoadjuvant and adjuvant treatment of breast cancer. So we designed this one center single arm phase 2 clinical trial to test the efficacy and safety of camrelizumab (PD-1 inhibitor) combined with vinorelbine and cisplatin as a second-line therapy for HER2 negative breast cancer patients who did not achieve significant effect after 2 cycle treatments of anthracycline plus taxanes NACT. The target population of our study are early-stage HER2 negative breast cancer patients with indications of NACT who did not receive partial response after 2 cycle of standard anthracycline and taxanes treaments according to RECIST 1.1 criteria. The enrolled patients will receive 6 cycles of camrelizumab combined with vinorelbine and cisplatin as second-line neoadjuvant therapy. Then they need to undergo surgery. The subjects have to continue camrelizumab until it is totally used for 1 year (about 17 cycles in all). The patients will routinely receive conventional adjuvant therapy and enter the long-term follow-up to get their survival infoumation.
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine...
Breast CancerThis is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.