Pouso Alegre

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.

Researchers are evaluating treatments for adults with early-stage (stage II to IIIB) non-small cell lung cancer who are scheduled for surgery. The study aims to compare an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug against cemiplimab plus chemotherapy alone. The trial also explores side effects of these treatments, effects on the type of surgery performed, drug levels in the blood, and whether the body produces antibodies that might affect the treatment's effectiveness or cause side effects. Participants receive treatments through intravenous infusions. One group receives cemiplimab plus chemotherapy, while the other group receives cemiplimab, chemotherapy, and an additional drug called REGN7075. The treatments are given before surgery with the goal of shrinking tumors. The study is a randomized Phase 2 platform trial designed to assess these combined therapies in a perioperative setting. During the study, participants undergo evaluations including pathology reviews up to 12 weeks after treatment to determine tumor response. Researchers monitor major pathological responses and collect tumor samples. Safety and side effects are closely followed. Overall, the study involves treatment, surgery, and follow-up assessments to understand how well the treatments work and their safety profiles.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

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.

Researchers are evaluating the use of extreme hypofractionated radiotherapy in women diagnosed with breast cancer across Brazil. This retrospective cohort study aims to analyze the national experience by assessing oncological outcomes and side effects in selected patients treated with this radiation protocol. The goal is to better understand the effectiveness and safety of this treatment approach in routine clinical practice. The study involves collecting data from medical records of patients who underwent extreme hypofractionated radiotherapy, specifically five sessions of 5.2 Gy each, after surgery. Eligible patients are women over 18 years old with any molecular subtype of breast cancer treated from December 2019 onward. Data collection will take place at various centers across Brazil, with up to 500 patients expected to be included. No new treatments or interventions are given as part of this study. Participants continue to receive their usual clinical care and follow-up according to their medical teams. Researchers will gather information on demographic, clinical, and treatment details from the records. The main outcome measured is locoregional recurrence within 18 months. This study relies entirely on existing medical data and does not involve additional procedures or visits for participants.