Sao Luis

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are investigating the safety and effectiveness of crizanlizumab compared to a placebo in adolescents and adults aged 12 years and older who have Sickle Cell Disease and experience frequent vaso-occlusive crises (VOCs). This phase III, multicenter, randomized, double-blind study includes patients who have had between 4 and 12 healthcare professional-managed VOCs in the past year. Participants may or may not be taking hydroxyurea or hydroxycarbamide therapy alongside the study treatment. Participants will be randomly assigned in a 2:1 ratio to receive either crizanlizumab at a dose of 5 mg/kg or a placebo, both given as intravenous infusions. The randomization is stratified based on whether they are using hydroxyurea/hydroxycarbamide and by geographic region (South America, North America, and sub-Saharan Africa). Crizanlizumab and placebo are provided in single-use vials for infusion. Treatment will be monitored over a planned period of at least 52 weeks. Throughout the study, participants will be closely monitored for the number of VOCs that require healthcare professional management, including those handled in a healthcare facility or remotely, over one year. Medical history, laboratory tests, and other assessments will be used to document VOCs and evaluate safety. Participants who are on hydroxyurea/hydroxycarbamide or erythropoietin stimulating agents must maintain stable doses during the study. The study aims to assess both the rate of VOCs and the overall safety profile of crizanlizumab in this patient population.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Adrenocortical carcinoma is a rare cancer, but in Brazil, particularly in the South and Southeast, its occurrence is about 15 times higher than in other parts of the world due to a common genetic mutation called TP53-R337H. This research aims to study the clinical and epidemiological characteristics of people diagnosed with this cancer in Brazil from the year 2000 onward, focusing on identifying factors that may influence patients' outcomes. The study builds on a previous group of 66 patients treated at a major cancer center and seeks to include additional cases from key Brazilian treatment sites. This is a retrospective observational cohort study, meaning researchers will review past medical records of patients diagnosed with adrenocortical carcinoma who received care at participating centers. The study does not involve new treatments or interventions but analyzes existing clinical, pathological, and treatment data. Participants are identified from records starting in 2000, and their information is collected to better understand the disease in this population. Participants' medical records will be examined for demographic details and clinical characteristics over an average follow-up period of 18 months. Researchers will evaluate clinical evaluations, pathology reports, and treatment data to characterize the disease and its progression. The study focuses on gathering information to improve knowledge about adrenocortical carcinoma in Brazil, with no active treatment or direct participant visits involved.

Researchers are investigating breast and prostate cancer in patients treated through the Brazilian Unified Health System. The study focuses on understanding molecular changes in tumors, including genetic mutations that arise during cancer development, which can influence treatment responses and disease outcomes. It also aims to identify hereditary genetic syndromes to improve cancer follow-up and risk prediction. This effort supports the Brazilian Ministry of Health's National Precision Genomics and Health Program, Genomas Brasil, while collecting data on the population's ancestry. The project involves detailed genetic testing using whole exome and whole genome sequencing. For prostate and HER2-positive breast cancer, both somatic and germline whole exome sequencing will be conducted. For triple-negative breast cancer, somatic whole exome and germline whole genome sequencing will be analyzed. These tests are performed on tumor tissue and blood samples to map genetic variations linked to these cancers. Participants will provide tumor tissue and blood samples for genetic analysis. The study will characterize the complete somatic and germline exomes and genomes over a 12-month period. Researchers will collect clinical and genomic data to better understand cancer genetics and ancestry. Consent is required before inclusion, and the study monitors the genetic profiles of breast and prostate cancer patients to support precision medicine efforts in Brazil.

Researchers are evaluating the safety and effectiveness of palazestrant (OP-1250) compared to standard treatments fulvestrant or an aromatase inhibitor in adults with ER-positive, HER2-negative advanced or metastatic breast cancer. Participants have previously received endocrine therapy combined with a CDK4/6 inhibitor, and their cancer has progressed despite this treatment. This phase 3, international, randomized, open-label trial aims to provide new information on treatment options for this population. Participants will be assigned to receive either palazestrant daily in a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or standard endocrine therapy with fulvestrant or one of three aromatase inhibitors (anastrozole, letrozole, or exemestane), given according to their approved schedules. After selecting the optimal palazestrant dose, more participants will be randomized to receive either that dose or standard care. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for adverse events, dose reductions, or treatment discontinuation for up to 16 weeks after randomization. The main outcome is progression-free survival, measured until disease progression or death, with an estimated follow-up of up to 2 years. Assessments will include physical exams, lab tests, and regular evaluations of cancer status and side effects to ensure safety and track the effectiveness of the treatments.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab given every 4 weeks or every 12 weeks compared to placebo, all combined with standard-of-care therapy, in adults with active lupus nephritis. This phase 3 trial focuses on participants with specific classes of lupus nephritis confirmed by recent kidney biopsy and meeting established diagnostic criteria. Participants will receive either ianalumab every 4 weeks, ianalumab every 12 weeks, or a placebo, all given by subcutaneous injection alongside standard lupus nephritis treatment. Standard-of-care includes induction therapy with high-dose corticosteroids and mycophenolic acid (MPA). Treatment schedules and doses are carefully monitored throughout the study. Participants will be involved in regular assessments including kidney function tests, urine protein measurements, and clinical evaluations up to week 72 to monitor treatment response and safety. The primary outcome is the frequency of participants achieving stable complete renal response by week 72. Safety and tolerability are also closely tracked during the trial period.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.

Researchers are evaluating the safety, tolerability, and effectiveness of acalabrutinib combined with rituximab in elderly and/or frail patients who have not been treated before and have diffuse large B-cell lymphoma (DLBCL). This study focuses on patients who are unsuitable for standard chemoimmunotherapy treatments. It is a Phase II, single-arm, open-label trial designed to assess treatment outcomes in this specific population. Participants will receive acalabrutinib orally according to a dosing schedule and rituximab via intravenous infusion on Cycle 1 Day 15, followed by subcutaneous injections on Day 1 of Cycles 2 through 8. The treatment period lasts up to 104 weeks with up to 8 cycles of rituximab and up to 28 cycles of acalabrutinib, both starting from cycle 1. Before treatment, there is a screening period of up to 28 days. During the study, patients will be monitored for adverse events and treatment effects over a total duration of up to 108 weeks, including treatment and follow-up. The primary outcome measured is the percentage of patients experiencing Grade 3 to 4 treatment-emergent adverse events from the start of treatment through 30 days after discontinuation, with observation lasting up to 3.5 years. Assessments will include physical health evaluations, imaging scans, and laboratory tests to monitor disease status and safety.