La Chaussee Saint Victor

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 exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are gathering real-world data on patients aged 70 years and older who are receiving first-line treatment for thoracic tumors, specifically Non-Small-Cell Lung Carcinoma (NSCLC). This Phase 4 study aims to characterize patients in terms of their geriatric, biological, and cancer-related features. It will also describe treatment methods by disease stage and evaluate outcomes related to treatment effectiveness, safety, and quality of life. Subgroups of patients treated with the same medication or innovative strategies will also be explored. Participants will receive systemic treatments that are authorized and available through standard care or compassionate use. Blood samples will be collected before starting treatment and stored in a biobank for up to 10 years. Quality of life will be assessed using specific questionnaires at various time points depending on disease stage and treatment type. Geriatric assessments including autonomy scales, cognitive tests, depression screening, fall history, and social environment evaluations will be performed. During the study, participants will follow their usual clinical care with regular visits, laboratory tests, imaging, and biopsies as needed to monitor their general health, treatment effectiveness, and side effects. They will complete quality of life questionnaires and undergo assessments tailored for older adults. Researchers will measure progression-free survival, defined as the time from first treatment dose until disease progression or death, with follow-up lasting up to two years.

Researchers are conducting a global, multicenter, randomized, open-label Phase 2/3 trial to study the effects of Datopotamab Deruxtecan (Dato-DXd) combined with carboplatin or cisplatin versus gemcitabine combined with carboplatin or cisplatin. This study focuses on participants with locally advanced or metastatic urothelial carcinoma (la/mUC) who have experienced disease progression during or after treatment with enfortumab vedotin (EV) plus pembrolizumab. The research aims to assess preliminary efficacy, safety, and tolerability, and to identify the recommended Phase 3 dose (RP3D) based on Phase 2 results before proceeding to the Phase 3 portion. Dato-DXd will be given as an intravenous infusion every three weeks at a dose of 4 mg/kg or 6 mg/kg during Phase 2 or the RP3D during Phase 3. Carboplatin and cisplatin will also be administered intravenously every three weeks, with carboplatin dosed at AUC 4.5 or 5.0 mg·min/mL and cisplatin at 70 mg/m2. Gemcitabine will be given intravenously at 1000 mg/m2 on Days 1 and 8 of each three-week cycle. Participants eligible for cisplatin will receive it; those ineligible will receive carboplatin. The study starts with Phase 2 (Part A) to assess early outcomes and safety, then moves to Phase 3 (Part B) depending on those findings. Participants will be monitored for overall response rate, progression-free survival, and overall survival over periods up to 34 months in Phase 2 and 38 months in Phase 3. Assessments include radiographic evaluations to document disease progression or death. Safety and treatment tolerability will be closely observed throughout. Participants will provide tumor tissue samples for biomarker testing, and dosing will be tailored based on eligibility and investigator judgment. This comprehensive monitoring aims to evaluate the treatments' impact and patient outcomes over the study duration.

Researchers are evaluating if adding local ablative therapy (LAT) to systemic brigatinib treatment improves outcomes in adults with advanced non-small cell lung cancer (NSCLC) that has an ALK gene rearrangement. This phase two trial focuses on patients whose cancer shows a response or stable disease after 3 to 9 months of brigatinib treatment and have an oligometastatic disease, defined as five or fewer metastatic lesions with no more than two per organ. The study aims to optimize treatment timing when brigatinib is most effective in controlling cancer progression. Participants who meet specific criteria will receive local ablative treatments such as surgery, stereotactic radiosurgery, or thermal ablation, alongside continued brigatinib therapy. The local ablative therapy will be applied only if the tumor targets are accessible and confirmed by an expert panel. The trial is conducted across multiple sites in France and plans to enroll approximately 45 participants. During the study, participants will visit the clinic before LAT for eligibility assessment, at LAT administration, and then for follow-up visits every 8 weeks during the first year, followed by every 12 weeks up to 3 years. Assessments include tumor evaluations through CT scans, MRIs, blood tests for hematology, chemistry, and liver function, as well as pregnancy tests when applicable. Researchers will monitor progression-free survival for up to three years and evaluate safety and treatment effects throughout the study.