Kadikoy

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 investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.