Bezannes

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.

Researchers are evaluating the safety and effects of Abrocitinib, a medication given as a tablet once daily, for adults with moderate to severe atopic dermatitis (AD), a long-lasting skin condition causing inflammation, redness, and irritation. This observational cohort study aims to understand how Abrocitinib works in real-life clinical settings and its impact on patients with moderate-to-severe chronic AD who are eligible to receive this treatment. All participants will receive Abrocitinib daily and may continue using medicated topical treatments for their AD at the same time. The study lasts for 24 months, during which participants will visit the study clinic approximately five times, or about once every four to six months. These visits will allow researchers to monitor the effects and safety of the treatment in a real-world context. Participants will be closely observed for changes in their AD severity, specifically looking for improvements measured by the Investigator's Global Assessment (IGA) score at 16 weeks. The study will also assess safety and how patients manage their treatment over time. Overall, the study aims to provide valuable information on how Abrocitinib affects adults with moderate-to-severe atopic dermatitis in everyday clinical practice.

Researchers are evaluating the safety and effectiveness of brivekimig in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. This Phase 2b, global, multi-center study is designed as a randomized, double-blind, placebo-controlled trial that tests different doses of brivekimig. The study aims to understand how well brivekimig works compared to a placebo in improving HS symptoms and to find the best dose. Participants will receive either brivekimig or a placebo as a subcutaneous injection. The study includes a dose-ranging phase followed by a maintenance period. The total duration of treatment in the randomized phase can last up to approximately 48 weeks. For those not entering the long-term extension, the study duration will be about 60 weeks, and for those transitioning to the long-term extension, it will be about 52 weeks. During the study, participants will be monitored regularly to assess their response to treatment, including the percentage achieving a clinical response called HiSCR75 by Week 16. Researchers will evaluate safety and efficacy through clinical assessments and follow participants throughout the study period. The total involvement per participant lasts up to around 60 weeks depending on extension study participation.

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.

Researchers are investigating treatments for advanced metastatic adenocarcinoma of the stomach and gastro-esophageal junction, a serious cancer with low survival rates. Current treatments include chemotherapy combinations and immunotherapy, which have improved outcomes for some patients. However, when cancer progresses after these therapies, options are limited, and new approaches are needed to extend survival and maintain quality of life. This international Phase III trial (FRUQUITAS) tests whether adding fruquintinib, an anti-angiogenic drug, to the oral chemotherapy drug trifluridine/tipiracil can improve survival for patients whose cancer has continued to grow despite prior treatments. The study compares two groups: one receiving trifluridine/tipiracil alone and the other receiving trifluridine/tipiracil combined with fruquintinib. Trifluridine/tipiracil is given orally twice daily on days 1 to 5 and days 8 to 12 of a 28-day cycle, repeated until disease progression or unacceptable side effects. Fruquintinib is taken orally once daily for 21 days of a 28-day cycle, also continued until progression or toxicity. This combination aims to block the tumor's blood supply while providing chemotherapy. The trial evaluates if this approach extends overall survival compared to chemotherapy alone. Participants will be adults with metastatic adenocarcinoma who have received two or three previous treatment lines. They will undergo regular assessments including tumor evaluations per RECIST criteria, blood tests to monitor organ function, and safety checks. Researchers will measure overall survival up to 18 months after starting treatment. The study involves ongoing monitoring for side effects and treatment tolerance, with participation lasting until disease progression, unacceptable toxicity, or withdrawal. Biological samples may also be collected for further research, and informed consent is required before enrollment.

Researchers are conducting an ambispective, observational, multicenter, and multicohort study focusing on patients with non-small cell lung cancer (NSCLC) who are starting treatment with approved drugs developed by AstraZeneca (AZ) or as part of an AZ alliance. The study includes three groups based on NSCLC stage: resectable, unresectable, and metastatic. This modular study design allows assessment of each new drug indication once it receives European marketing authorization and becomes available in the participating countries. Patients will be enrolled if they have received, are receiving, or will receive approved AZ or AZ alliance drugs either alone or in combination, at any disease stage. Treatment decisions are made by the patients' own doctors before joining the study. The study follows these patients in three cohorts: resectable NSCLC, unresectable NSCLC, and metastatic NSCLC, to evaluate outcomes related to drug effectiveness in real-world settings. Participants will be followed for up to three years to measure outcomes such as disease-free survival, event-free survival, and time to treatment failure, depending on their cohort. Data collection includes retrospective and prospective information on treatment start and patient progress. The study emphasizes real-world evidence by observing patients receiving standard care without intervention from the study team.