Alfenas

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.

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.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating eye health in patients with breast cancer through a multicenter study. The study aims to assess ophthalmic safety by comparing two groups of patients concurrently to account for age-related changes and worsening of existing eye conditions. The study period for ophthalmic assessments will last approximately 12 months to minimize additional burden on participants. The study includes two parallel cohorts, each with at least 60 participants. Ophthalmic examinations will be conducted at the same time points for both groups. These assessments involve tests such as visual acuity using Snellen units, slit lamp examinations, optical coherence tonometry, and fundus examinations to monitor eye health. Participants will undergo ophthalmic evaluations performed by local ophthalmologists and central readers up to 28 days after the study ends. These evaluations include eye scans and detailed eye health reviews. The study monitors changes in vision and eye structure and safety throughout the 12-month period, ensuring participants' eye health is closely observed.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

This research aims to compare two surgical methods, the tunnel technique and laterally closed tunnel technique, with the free gingival graft (FGG) technique for treating isolated or multiple gum recessions in the front lower jaw. The study also plans to evaluate how a gel made with hyaluronic acid and green tea affects healing at the area where the graft is taken from the palate. The goal is to provide clearer evidence about the effectiveness of the tunnel technique as an alternative to FGG in treating these gum recessions. Participants will be divided into four groups based on the treatment received: two groups will get either the tunnel technique or laterally closed tunnel technique, while two control groups will receive the FGG technique for either multiple or isolated gum recessions. For the donor site on the palate, participants will be split into two groups: one applying the hyaluronic acid and green tea gel three times daily for seven days, and the other having only the natural clot maintained by sutures. All surgical procedures involve carefully prepared incisions, tissue dissection, and graft placement, with sutures used to secure tissues. Participants will be monitored at the start and then at 1, 3, 6, and 12 months after surgery to assess gum recession depth changes. The donor area will be evaluated at 3, 7, 15, and 30 days for wound healing, including closure rate, surface area healing, and tissue color. Pain and aesthetic outcomes will be recorded using visual scales for both donor and recipient areas. These evaluations will help measure the success and participant experience of each treatment over time.