La Chaussee Saint Victor

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

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 investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are collecting real-life data on patients aged 70 years and older who are receiving first-line treatment for thoracic tumors, specifically Non-Small-Cell Lung Carcinoma, following standards defined by the European Society for Medical Oncology. The study aims to characterize participants geriatric health, biology, and cancer features, as well as to describe treatment methods and assess outcomes such as efficacy, safety, and quality of life. Exploratory subgroups treated with the same drug or innovative strategies will also be identified. Participants will undergo systemic treatment for their lung cancer according to current standard care or innovative therapies. Blood samples will be collected before the first treatment for biobanking, and tumor samples will be sent for central analysis. Patients will attend clinic visits as per usual care and will complete three quality of life questionnaires during the study. Throughout the study, participants will have regular visits and tests to monitor their general condition and treatment effects. This includes lab tests, imaging, re-biopsies, and assessments tailored for older adults. Quality of life is measured at several time points using validated questionnaires. The main outcome being tracked is progression-free survival up to two years, along with other outcomes like response rates, overall survival, safety events, and geriatric interventions. Participants may be followed for up to two years in total.

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 evaluating treatments for adults with locally advanced or metastatic urothelial carcinoma bladder cancer who have progressed after prior therapy with enfortumab vedotin EV plus pembrolizumab. This global, multicenter, randomized, open-label Phase 23 trial compares a new drug, Datopotamab Deruxtecan Dato-DXd combined with either carboplatin or cisplatin, against the standard gemcitabine combined with carboplatin or cisplatin. The study aims to identify the recommended dose for Phase 3 and assess preliminary safety and efficacy during Part A, followed by a larger Phase 3 evaluation. Participants in Part A receive Dato-DXd at doses of 4 mgkg or 6 mgkg with platinum chemotherapy every three weeks. In Part B, participants receive the selected recommended dose of Dato-DXd or gemcitabine, each combined with either carboplatin or cisplatin, administered intravenously every three weeks. The specific platinum drug and dosing schedule are based on eligibility and investigator judgment, including options for split-dose cisplatin in certain cases. During the trial, participants undergo regular assessments including imaging scans to monitor tumor response, safety evaluations, and laboratory tests. The primary outcomes include overall response rate in Phase 2 and progression-free survival and overall survival in Phase 3, tracked up to approximately 34 to 38 months. Participants are followed throughout treatment and for a period afterward to evaluate treatment effects and safety under medical supervision.

This trial investigates whether giving systemic Brigatinib along with local ablative therapy LAT at the time when Brigatinib is working best can improve outcomes for adults with advanced non-small cell lung cancer NSCLC that has an ALK gene rearrangement. This type of alteration leads to abnormal proteins causing cancer cells to multiply. The study involves participants whose cancer has responded or stabilized after 3 to 9 months of Brigatinib treatment and who have a limited number of metastatic lesions suitable for LAT. Participants who meet criteria will receive LAT such as surgery, stereotactic radiosurgery SRS, or percutaneous thermal ablation for liver or adrenal metastases, while continuing Brigatinib. The disease status will be evaluated between 3 to 9 months after starting Brigatinib to confirm tumor response or stabilization and check that all tumor targets are accessible to LAT as reviewed by an expert panel. During the study, participants will visit the clinic for eligibility assessment prior to LAT, receive LAT, then undergo regular check-ups every 8 weeks for the first year after LAT and every 12 weeks thereafter, for up to 3 years. Researchers will monitor progression-free survival and overall survival, along with safety and treatment duration. Assessments include imaging scans, laboratory blood tests, and pregnancy tests for women of childbearing potential.