Horovice

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Researchers are evaluating BMS-986365 compared to the investigators choice of therapy in men with Metastatic Castration-resistant Prostate Cancer. This phase 3, randomized trial aims to assess how well BMS-986365 works and how safe it is, focusing on radiographic progression-free survival. The study includes participants who have previously been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants are randomized into groups receiving either one of two dose levels of BMS-986365 or an active comparator treatment chosen by the investigator, which includes either Docetaxel plus PrednisonePrednisolone or Enzalutamide or Abiraterone plus PrednisonePrednisolone. The study has two parts Part 1 compares the different doses and comparator arms, while Part 2 focuses on the selected BMS-986365 dose versus the investigators choice. Dosing schedules are specified but not detailed here. During the study, participants undergo regular assessments including imaging scans to evaluate cancer progression, pain and symptom questionnaires, blood tests, electrocardiograms, and monitoring for adverse events. Outcomes measured include progression-free survival, overall survival, response rates, pain progression, and quality of life changes. The study may last up to 4 years, with ongoing safety and efficacy evaluations throughout this time.

Overactive bladder OAB is a common health issue affecting 15-20% of adults, but less than half seek medical help. This research aims to raise awareness of OAB and improve referrals to specialists who can provide appropriate diagnosis and treatment. The project is led by the Institute of Health Information and Statistics of the Czech Republic and focuses on early detection and reducing the negative impact of OAB on quality of life. The study uses an online screening tool available via a web platform and mobile app, where participants complete validated questionnaires related to OAB symptoms, personal and family history, and quality of life. Those with positive screening results are offered an examination by specialists such as gynecologists, urogynaecologists, or urologists. Specialists access participant profiles through the platform, confirm or rule out OAB, perform additional diagnostic tests if needed, and set up standard treatments. Participation requires consent to data processing under GDPR. Participants will provide data through the online tool and may attend follow-up examinations with specialists. The study tracks outcomes including the number of participants completing the screening, those agreeing to specialist visits, confirmed diagnoses, and follow-up attendance over an average period of six to nine months. Data collected will evaluate the pilot projects effectiveness and cost, with all information stored securely respecting privacy regulations.

Researchers are evaluating a treatment for advanced breast cancer that is estrogen receptor-positive, HER2-negative, and has a specific ESR1 gene mutation. The study aims to find out how well a combination of elacestrant, a selective estrogen receptor degrader, and everolimus, a kinase inhibitor, works in patients whose cancer has progressed despite prior endocrine therapy and CDK46 inhibitor treatment. The study follows strict guidelines to ensure patient safety and compliance with international clinical standards. Participants will be randomly assigned to one of two groups. One group will receive elacestrant at 345 mg plus everolimus at 7.5 mg orally once daily, while the other group will receive elacestrant at the same dose plus a placebo instead of everolimus. Treatments will be given in 28-day cycles and continue until disease progression, unacceptable side effects, or other reasons for stopping the treatment occur. After stopping treatment, patients will be followed every three months for up to one year to monitor survival and any new cancer therapies. During the study, patients will undergo scans such as CT or MRI to confirm disease status, and tests to assess tumor markers and gene mutations. Researchers will monitor treatment effects, safety, and quality of life using questionnaires like the EQ-5D-5L and EORTC QLQ-C30 and QLQ-BR42. Side effects, blood counts, liver and kidney function, heart activity, and overall health status will be regularly checked. The main outcome is progression-free survival, measuring how long patients live without cancer worsening during treatment, with other outcomes including overall survival and treatment response. The total study duration for each participant averages about 12 months.

Researchers are evaluating the effectiveness and safety of palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with advanced breast cancer that is estrogen receptor positive ER and human epidermal growth factor receptor 2 negative HER2-. This phase 3 clinical trial includes women and men who have not yet received systemic treatment for their advanced breast cancer, aiming to find improved first-line treatment options. Participants are randomly assigned to one of two groups one group receives palazestrant 90 mg daily with ribociclib 600 mg daily taken on days 1-21 of each 28-day cycle plus a placebo matching letrozole the other group receives letrozole 2.5 mg daily with ribociclib 600 mg daily plus a placebo matching palazestrant. Treatments are given in repeating 28-day cycles. The study is double-blind and active-controlled, meaning neither participants nor researchers know who receives which treatment, and both groups receive active drugs. During the trial, participants will be monitored regularly for disease progression and survival over approximately 3.5 to 5.5 years. Assessments include tumor response evaluations, safety and tolerability checks, pharmacokinetic blood tests every 28 days, and patient-reported health outcomes. The primary outcome is progression-free survival, measuring the time from randomization until disease worsens or death. Safety monitoring continues for up to 42 days after treatment ends, with the study lasting until 2032.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating the efficacy and safety of combining gedatolisib and palbociclib with endocrine therapy compared to endocrine therapy and ribociclib in adults with hormone receptor-positive, HER2-negative advanced breast cancer. This Phase 3, open-label, randomized clinical trial involves patients with locally advanced or metastatic breast cancer who have either endocrine-resistant or endocrine-sensitive disease. The study aims to explore treatment options for this specific breast cancer subtype to improve outcomes for patients. Participants are assigned to one of two studies based on their endocrine sensitivity status. Study 1 includes patients with endocrine-resistant cancer who will receive either intravenous gedatolisib combined with oral palbociclib and intramuscular fulvestrant or oral ribociclib with fulvestrant. Study 2 includes endocrine-sensitive patients who will receive intravenous gedatolisib with oral palbociclib and letrozole or oral ribociclib with letrozole. Treatments are administered in cycles with specific dosing schedules, including weekly intravenous infusions and oral medications over 28-day cycles. During the trial, participants will undergo screening to confirm eligibility before randomization. Researchers will monitor progression-free survival for up to 48 months as the primary outcome, along with secondary outcomes such as overall survival, response rates, duration and time to response, clinical benefit, quality of life, and adverse events. Safety follow-up will occur 30 days after treatment, and ongoing assessments will include imaging, tumor biopsies, laboratory tests, and quality of life questionnaires. The study is expected to last several years with continuous monitoring of patient health and treatment effects.

Researchers are studying advanced breast cancer patients who have mutations in BRCA1, BRCA2, or PALB2 genes and whose cancer is hormone receptor-positive and HER2-negative. The study aims to compare the effectiveness of saruparib AZD5305 combined with camizestrant against standard treatments involving CDK46 inhibitors plus endocrine therapy. This is a phase III clinical trial conducted to evaluate treatment options for this specific breast cancer group. Participants will be randomly assigned to one of four treatment groups saruparib plus camizestrant physicians choice of CDK46 inhibitor plus endocrine therapy physicians choice of CDK46 inhibitor plus camizestrant or saruparib plus physicians choice endocrine therapy. Treatments are given orally or by injection according to the group, and continue until the disease progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo assessments to monitor disease progression and treatment effects, including scans and laboratory tests. Researchers will measure progression-free survival and other outcomes such as overall survival, response rates, and quality of life over several years. Safety and tolerability will also be closely observed throughout the study period, which may last up to about 88 months.