View clinical trials related to Breast Cancer.
Filter by:OBJECTIVE: To evaluate the effectiveness of a PET scan in oncological patients, with and without simultaneous treatment with chemotherapy, radiotherapy or hormonal therapy, in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention. DESIGN: Randomized controlled clinical trial, parallel groups with active control group. With randomization blinding, patient assessment and data analysis. STUDY SUBJECTS: 78 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (aromatase inhibitors, tamoxifen). INTERVENTION: three treatment groups: supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy, radiotherapy or hormonal treatment, supervised therapeutic exercise group with simultaneous chemotherapy, radiotherapy or hormonal treatment and control group. Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised. Patients will be followed for 1 year, with five blinded assessments: at baseline, after 6 weeks of intervention, 3, 6 and 12 months after baseline. MEASUREMENTS: Main: Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Measured pre-post intervention, 3, 6 and 12 months. Secondary: Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Measured pre-post intervention, 3, 6 and 12 months. Functional capacity measured with the 6-minute walk test. Pre-post intervention measurement, 3, 6 and 12 months. Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test. Pre-post intervention measurement, 3, 6 and 12 months.
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
The aim of the study is to assess the efficacy of fenofibrate in either reversing and/or preventing the development of PIPN in breast cancer patients treated with paclitaxel-based regimen. The primary outcome :clinical improvement of neuropathic pain and grade by 1-CT-CTCAE -VERSION-4 & FACT/GOG-NT-12 questionnaire and its effect on quality of life (QOL). The secondary outcome : the efficacy of fenofibrate in either reversing and/or preventing the development of PIPN via alteration of either Nerve growth factor (NGF) or/ and/( NFL).
The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.
The multicenter, two-cohort, non-comparative, open-label, phase II clinical trial SABINA aims to analyze the safety and efficacy of MEN1611 in monotherapy and in combination with eribulin, a non-taxane chemotherapy agent, in Hormone Receptor (HR)-known/Human Epidermial Growth Factor Receptor 2 (HER2)-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/ Phosphatase and Tensin Homolog (PTEN)-altered, unresectable locally advanced or metastatic metaplastic breast carcinoma (MpBC) patients. A run-in phase for safety and tolerability of MEN1611 in combination with standard doses of eribulin will be conducted as an initial step of the cohort A. This first step aims at evaluating the dosing schedule of MEN1611, by analyzing the toxicity profile of the combined regimen. With the background of the first-in-human study (PA-001EU), the safe dose of MEN1611 has been established as 48 mg orally BID (two intakes of 3 capsules of 16 mg each, for a total daily dose of 96 mg MEN1611 free-base).
Electronic health records (EHRs) are an increasingly common source for populating risk models, but whether used to populate validated risk assessment models or to de-facto build risk prediction models, EHR data presents several challenges. The purpose of this study is to assess how the integration of patient generated health data (PGHD) and EHR data can generate more accurate risk prediction models, advance personalized cancer prevention, improve digital access to health data in an equitable manner, and advance policy goals for Patient Generated Health Data (PGHD) and EHR interoperability.
Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer
Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one. Furthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients. Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.
The purpose of this study is to determine if the triplet combination of dalpiciclib, fulvestrant, and pyrotinib is safe and effective in the treatment of hormone receptor-positive, HER2-low locally advanced/metastatic breast cancer following treatment with an aromatase inhibitor plus a CDK4/6 inhibitor (palbociclib abemaciclib or ribociclib). The study will employ a Bayesian Optimal Phase II (BOP2) design which explicitly controls the type I error rate, thereby bridging the gap between Bayesian designs and frequentist designs, and has favorable operating characteristics with higher power and lower risk of incorrectly terminating the trial than some existing Bayesian phase II designs.