Horovice

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 how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

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.

Overactive bladder (OAB) is a common health issue affecting many adults, with about 15-20% of the population experiencing it. This research aims to increase awareness and ensure that people with OAB symptoms are correctly referred to specialists such as gynecologists, urogynaecologists, or urologists for proper diagnosis and treatment. The study uses an online screening tool to identify individuals who might have OAB and need specialist evaluation. Participants will use a web platform or mobile app to complete validated questionnaires about their urinary symptoms, personal and family medical history, and quality of life. Those with positive screening results will be referred to a specialist who can access their screening data through the platform, perform further diagnostic tests if needed, confirm or rule out OAB, and decide on appropriate treatment. The study also includes a public relations campaign to encourage participation and improve awareness. During the study, participants will complete the online screening and may attend face-to-face specialist visits for diagnosis. Researchers will monitor the number of participants who complete the screening, the percentage of those with suspected OAB agreeing to follow-up, those diagnosed by specialists, and those who attend follow-up visits up to nine months. The data collected will help evaluate the screening process and its impact on quality of life, with attention to safety and privacy under GDPR.

Researchers are evaluating treatments for advanced breast cancer characterized by estrogen receptor-positive, HER2-negative, and ESR1-mutated tumors. This study focuses on patients whose cancer has progressed despite previous endocrine therapy and CDK4/6 inhibitor treatment. The goal is to determine the effectiveness of combining elacestrant, a selective estrogen receptor degrader, with everolimus, a kinase inhibitor, compared to elacestrant with a placebo. This phase 3 trial aims to assess how well these treatments prolong the time patients live without disease progression or unacceptable side effects. A total of 240 patients will be randomly assigned to one of two groups: one receiving 345 mg of elacestrant plus 7.5 mg of everolimus daily, and the other receiving 345 mg of elacestrant plus a placebo daily. Treatment cycles last 28 days and continue until disease progression, unacceptable toxicity, death, or other reasons for stopping. Patients will be grouped based on the presence of visceral metastases and prior duration of CDK4/6 inhibitor therapy. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are tracked every three months for up to 12 months after the last patient is enrolled. Participants will undergo regular assessments including imaging scans to monitor cancer status and safety evaluations. The main measure is progression-free survival, defined as the time from treatment start until tumor progression, death, or discontinuation for other reasons, monitored on average for 12 months. Safety and treatment effectiveness will be closely followed throughout the study, with additional tumor assessments for those who stop treatment for reasons other than progression until new cancer therapy begins, death, or disease progression occurs.

Researchers are evaluating the safety and effectiveness of elacestrant combined with other drugs in adults with advanced or metastatic estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. This multicenter Phase 1b/2 trial aims to find the recommended dose of elacestrant in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib in Phase 1b, and then assess the safety and efficacy of these combinations in Phase 2. During Phase 1b, participants receive elacestrant at various doses along with one of the other drugs, such as alpelisib, everolimus, ribociclib, palbociclib, capivasertib, or abemaciclib, in treatment cycles of 28 days. Phase 2 includes multiple treatment arms with fixed participant numbers per combination, evaluating these drug combinations over similar 28-day cycles. Each drug has specific dosing schedules, such as once daily or twice daily, with some requiring days off during the cycle. Participants will undergo assessments including monitoring for dose-limiting toxicities during the first 28-day cycle and progression-free survival over six months. The study involves regular evaluations of disease status and safety, including physical exams and laboratory tests. Overall, Phase 1b will have up to 125 participants, while Phase 2 will include about 310 participants across all treatment groups.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating the efficacy and safety of combining gedatolisib with fulvestrant and CDK4/6 inhibitors for treating patients with locally advanced or metastatic hormone receptor positive, HER2-negative (HR+/HER2-) advanced breast cancer. This Phase 3, open-label, randomized trial focuses on patients whose cancer progressed during or within 12 months of adjuvant endocrine therapy and who have not received prior systemic therapy for advanced breast cancer. The trial separates participants into groups based on PIK3CA mutation status and compares the investigational treatment to standard care. Participants receive either the investigational treatment of intravenous gedatolisib once weekly for three weeks followed by a week off, combined with oral palbociclib or ribociclib taken on days 1-21 of each 28-day cycle plus intramuscular fulvestrant every 2 weeks during the first cycle and then every 4 weeks, or the standard-of-care treatment of oral palbociclib or ribociclib with intramuscular fulvestrant on the same schedules without gedatolisib. The study includes a safety run-in phase to determine dosing of gedatolisib with ribociclib before randomization. Throughout the study, participants will undergo assessments to monitor progression-free survival, which is measured from randomization until death from any cause for up to approximately 48 months. Evaluations include tumor tissue or liquid biopsies for PIK3CA status, imaging to assess measurable disease, and monitoring of bone marrow, liver, kidney, and coagulation functions. Safety and efficacy are closely followed with ongoing clinical evaluations, and participants must have an expected life expectancy greater than six months for enrollment.