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Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are conducting a combined phase 2b and phase 3 study to evaluate the drug CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing dialysis. The study focuses on participants with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. The trial aims to find the best dose of CSL300 and then assess its effects on cardiovascular outcomes and safety compared to a placebo. The study is divided into two parts Part 1 phase 2b is a dose-finding phase where different doses of CSL300 are given intravenously to participants to determine the optimal dose versus placebo. Part 2 phase 3 evaluates the efficacy and safety of the selected CSL300 dose compared to placebo over approximately five years. All treatments are administered by intravenous infusion. Participants will be involved in regular assessments including blood tests to measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events tracking, and monitoring for adverse events. The phase 2b portion includes up to 24 weeks of follow-up for dose evaluation, while the phase 3 portion monitors cardiovascular outcomes like heart attacks or cardiovascular death over about five years. Safety and drug levels in the blood will also be closely observed throughout the study.

This research aims to observe the use of trastuzumab deruxtecan T-DXd in adults with HER2-low unresectable or metastatic breast cancer who have previously received chemotherapy in the metastatic setting or experienced disease recurrence within 6 months after adjuvant chemotherapy. The study will collect information on patient characteristics, how treatments are used, tolerability, management of side effects, and patient experiences with T-DXd, as well as data on conventional chemotherapy treatments in a registry. Participants will receive T-DXd or conventional chemotherapy as chosen by their doctors according to approved guidelines in routine clinical practice. No study drug is given by the research team since this is a non-interventional study. The conventional chemotherapy group will be analyzed separately to better understand treatment patterns and outcomes. During the study, researchers will gather data for up to 31 months, monitoring real-world time to next treatment, treatment patterns, safety events, use of treatments to manage side effects, and patient-reported outcomes including tolerability and quality of life. They will also track occurrences of nausea and vomiting through patient diaries. This information will help evaluate treatment use and patient experiences outside of clinical trial settings.

Bronchiectasis is a chronic lung condition marked by permanent widening of parts of the airway, causing mucus buildup, infections, and ongoing lung inflammation. This study evaluates whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis compared to enhanced standard care. The study is led by Physio-Assist and focuses on long-term effects over two years. Participants are randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device along with remote physiotherapy and standard care. The SIMEOX device helps clear mucus by delivering short negative air pulses through a mouthpiece. Remote physiotherapy sessions occur once a month for the first three months, then every three months thereafter. Use of the SIMEOX device is recommended daily or more often if needed. During the 24-month study, participants will be assessed at multiple points for changes in respiratory quality of life using questionnaires like the SGRQ, as well as lung function tests and tracking the frequency of lung exacerbations and hospitalizations. Researchers will monitor compliance with the device, adverse events, and other health outcomes. This comprehensive follow-up aims to understand the devices impact on patient wellbeing and lung health over the long term.

Researchers are studying a new way to give immunotherapy as maintenance treatment for patients with metastatic non-squamous lung cancer. This phase III clinical trial compares a pulse dosing schedule with a conventional dosing schedule to see if the less frequent pulse dosing is not worse than the standard treatment. The study focuses on pembrolizumab alone or combined with pemetrexed as the maintenance therapy after initial chemotherapy and immunotherapy induction. Participants are randomly assigned to one of two groups. In the Pulse arm, pembrolizumab 200 mg is given every 6 weeks, and pemetrexed 500 mgm is given every 3 weeks if there is no contraindication. In the Control arm, pembrolizumab is given either 200 mg every 3 weeks or 400 mg every 6 weeks, plus pemetrexed 500 mgm every 3 weeks when appropriate. This treatment is given after patients have completed 3 or 4 cycles of induction therapy with pembrolizumab plus platinum and pemetrexed. During the study, participants will be monitored for overall survival over 6 years, along with progression-free survival, response duration, quality of life using several questionnaires, treatment tolerance, and economic factors. Researchers will also perform population pharmacokinetic analyses and study the drugs effect on immune cells. Patients will undergo regular assessments including clinical evaluations and laboratory tests to track treatment effects and safety throughout the study period.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

Researchers are investigating factors that predict resistance to pembrolizumab, an immunotherapy drug used as the first treatment in patients with metastatic colorectal cancer that shows microsatellite instability or deficient mismatch repair. This study follows up on findings that about 20-30 of patients treated with pembrolizumab show primary resistance, highlighting a need to better identify which patients will benefit from this therapy and which may need other treatments. This research involves a national French cohort called CORESIM, combining both retrospective and prospective patient groups. Patients who started pembrolizumab treatment since February 2021 are included retrospectively, while new patients beginning pembrolizumab from February 2024 will be enrolled prospectively. Tumor samples and blood will be collected to analyze predictive biomarkers. The study expects to include about 600 patients over a 2-year enrollment period. Participants will be followed for 3 years to monitor outcomes and gather data on pembrolizumab resistance. Tumor archives and blood samples will be collected to support the research. The primary goal is to identify factors linked to treatment resistance. The study is observational, meaning it tracks patients receiving standard care without assigning treatments. This long-term follow-up helps researchers understand how different factors affect response to pembrolizumab in metastatic colorectal cancer.

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

Researchers are conducting a French non-interventional longitudinal multicenter cohort study to evaluate the added value of olaparib for treating patients with metastatic castration-resistant prostate cancer mCRPC in real-world settings. The study aims to assess treatment sequencing, effectiveness, safety, and BRCA testing patterns, helping to inform future clinical practice. This observational study is sponsored by AstraZeneca. The study observes adult male patients who have started olaparib treatment within at least the last two months or who participated in a funded early access program. There are no assigned treatment groups or interventions beyond olaparib use as decided by their physician. Data collection continues up to 32 months to capture treatment patterns and patient characteristics. Participants data on treatment duration, disease progression, therapy sequences, symptomatic skeletal events, and BRCA testing timing will be collected and analyzed up to 24 months from olaparib initiation. Socio-demographic and clinical characteristics of patients and physicians will be gathered at the end of enrollment. The study monitors reasons for dose changes, interruptions, and treatment cessation, ensuring comprehensive real-world evidence about olaparib in mCRPC patients.

Colorectal cancer mostly affects elderly patients, with over half diagnosed at age 70 or older in France. This research evaluates the benefit of adjuvant chemotherapy after surgical removal of stage III colon cancer in elderly patients, focusing on whether fluoropyrimidine-based or oxaliplatin-based chemotherapy improves disease-free survival. The study addresses concerns about the effectiveness of chemotherapy in very elderly or unfit patients and includes an assessment of tumor biological factors common in the elderly. Participants are divided into two groups based on a doctors evaluation involving a geriatrician, with different randomization assignments. Treatments being studied include chemotherapy regimens with LV5FU2 or capecitabine and FOLFOX4 or XELOX, as well as observation. The chemotherapy is started within 12 weeks after surgery. The study compares these approaches to determine the best adjuvant chemotherapy strategy for elderly patients. During the study, participants undergo assessments including geriatric questionnaires and monitoring of toxicities. Researchers measure disease-free survival three years after the last patient joins, along with overall survival at five years. Safety is evaluated by observing side effects graded by standard criteria. The study excludes patients with less than four years expected survival and ensures medical follow-up is possible. Participation duration and detailed monitoring support evaluating chemotherapy benefits in this population.