Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effects of pre-fabricated titanium abutments versus customized milled zirconia abutments on implant biocompatibility, peri-implant tissue health, radiographic bone loss, and oral health-related quality of life in single implant-supported posterior restorations. This randomized controlled clinical trial is part of the prosthetic phase following a previous study that involved tooth extraction, alveolar preservation, and implant placement with Morse Taper implants after a six-month healing period. The study aims to understand how abutment material and design influence peri-implant health and tissue stability over time. Participants are randomly assigned to receive either standardized titanium abutments or customized anatomical zirconia abutments connected to previously osseointegrated Morse Taper implants. Both groups receive single zirconia crowns installed using standardized digital prosthetic protocols. Clinical and laboratory assessments occur at prosthesis delivery (baseline) and at 1, 3, 6, and 12 months post-installation, ensuring consistent evaluation throughout the study period. During follow-up visits, researchers collect peri-implant crevicular fluid and biofilm samples for biomolecular analysis, assess periodontal clinical parameters, measure keratinized mucosa thickness, perform standardized periapical radiographs to monitor marginal bone levels, and conduct intraoral digital scans for soft tissue and volumetric analysis. The primary outcome measures focus on microbial colonization and peri-implant tissue stability, while secondary outcomes include bone level changes and soft tissue dimensional stability, all monitored over a 12-month timeframe.