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Found 7 Actively Recruiting clinical trials
Actively Recruiting
This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive ER, HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.
Actively Recruiting
Researchers are studying the safety and effects of Abrocitinib for adults with moderate to severe chronic atopic dermatitis, a long-lasting skin condition causing inflammation, redness, and irritation. The study focuses on real-life use of Abrocitinib to understand its impact and safety in this patient group. Participants must be over 18 years old without medical conditions that prevent using Abrocitinib. All participants will take Abrocitinib tablets once daily and may continue using medicated topical treatments alongside the study drug. The study lasts 24 months, during which participants will visit the clinic approximately five times, roughly once every 4 to 6 months. The study collects observational data to describe the effects and safety of Abrocitinib over this period. Participants will undergo assessments including skin evaluations using tools like the Investigators Global Assessment IGA and Eczema Area and Severity Index EASI. Researchers will monitor symptoms such as itch severity and sleep quality, along with treatment adherence and any side effects. Safety and effectiveness will be reviewed regularly throughout the study and at its end, with ongoing observation of treatment patterns and patient-reported outcomes.
Actively Recruiting
Researchers are evaluating the drug brivekimig in a Phase 2b study designed for adults with moderate to severe hidradenitis suppurativa HS, a chronic skin condition. This global, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety and effectiveness of different doses of brivekimig in participants with HS lasting at least six months. The study is sponsored by Sanofi and focuses on improving clinical response and quality of life for affected individuals. Participants will be randomly assigned to receive one of three different dose regimens of brivekimig or a matching placebo. The drug is given as a solution for injection under the skin. The treatment period lasts up to approximately 48 weeks, followed by either a maintenance phase or participation in a long-term extension study. The full duration of involvement is up to about 60 weeks for those not entering the extension and approximately 52 weeks for those who do. Throughout the study, participants will undergo regular assessments including clinical evaluations of HS severity, lesion counts, and pain levels using standardized scales. Quality of life will also be measured alongside monitoring for any adverse events or laboratory changes. The main outcome is the percentage of participants achieving a significant clinical response by week 16. Safety and drug levels will be monitored continuously until the end of the study.
Actively Recruiting
This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.
Actively Recruiting
This research aims to observe patients with HER2-negative early breast cancer in France who are treated with the drug Olaparib as part of their regular care. The study focuses on understanding how many patients complete the full course of adjuvant Olaparib treatment. It is a national, multicenter, prospective cohort study designed to gather real-world data on this patient group. The study follows patients who begin Olaparib treatment as decided by their doctors. There are no experimental treatments or placebo groups since this is an observational study. Researchers will monitor patients for up to 18 months after they start the Olaparib therapy to gather detailed information about treatment duration and patient characteristics. Participants will be observed throughout their treatment period, with data collected on how long they stay on Olaparib and any relevant medical history or genetic details such as BRCA mutation types. The main outcome measured is the proportion of patients completing the full 18-month treatment. Secondary outcomes include time to treatment discontinuation and variant types. No additional interventions are required, and the study monitors patients progress through their usual clinical visits.
Actively Recruiting
Researchers are studying advanced cancer of the stomach and the gastro-esophageal junction, a serious disease with low survival rates. The trial focuses on patients whose cancer has progressed after two or three prior treatments. The study aims to evaluate whether combining the oral drug trifluridinetipiracil with the anti-angiogenic drug fruquintinib can improve survival compared to trifluridinetipiracil alone. This international Phase III trial builds on recent advances in immunotherapy and targeted therapies for this cancer type. Participants are randomly assigned to one of two groups. One group receives trifluridinetipiracil alone in 28-day cycles, taking the drug by mouth twice daily on Days 1 to 5 and Days 8 to 12 with rest days in between, repeated every 4 weeks. The other group receives the same trifluridinetipiracil schedule plus fruquintinib by mouth once daily for 21 days each cycle. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants undergo regular assessments to monitor overall survival up to 18 months after starting treatment. Researchers will also measure progression-free survival during this period. Patients will have tumor evaluations, laboratory tests, and monitoring for treatment side effects. Participants must meet specific health criteria and agree to biological studies. The study provides close follow-up to evaluate the effects of the treatments over time.
Actively Recruiting
Researchers are conducting an ambispective, observational, multicenter, and multicohort study focusing on patients with non-small cell lung cancer NSCLC who are starting treatments with approved drugs developed by AstraZeneca or its alliance partners. The study includes three groups based on the stage of NSCLC resectable, unresectable, and metastatic. This modular study is designed to evaluate patients receiving these drugs once they have European marketing authorization and are available in the participating countries. Patients will be observed whether they have already received, are currently receiving, or will receive approved AstraZeneca drugs as monotherapy or in combination at any disease stage. The study tracks patients independently of treatment decisions made by their doctors. Each cohort represents a different stage of NSCLC, allowing specific assessment for each group. Participants will be followed to collect real-world data on outcomes such as disease-free survival, event-free survival, treatment failure times, response rates, progression-free survival, and overall survival over periods ranging from 3 to 5 years. Researchers will analyze treatment responses, recurrence-free survival, and treatment discontinuation times among other measures. The study involves no intervention from researchers on treatment plans and focuses on monitoring outcomes in routine clinical practice.