La Chaussee Saint Victor

This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive ER, HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.

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.

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.

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 studying treatments for people with locally advanced or metastatic urothelial carcinoma who have not responded to previous combination therapy with enfortumab vedotin plus pembrolizumab. This global, multicenter trial is a Phase 23 randomized, open-label study comparing a new drug called Datopotamab Deruxtecan Dato-DXd combined with carboplatin or cisplatin against the standard treatment of gemcitabine combined with carboplatin or cisplatin. The trial aims to assess preliminary effectiveness and safety in Phase 2 before determining the best dose for Phase 3 evaluation. Participants will receive Dato-DXd given as an intravenous infusion every three weeks at doses of 4 mgkg, 6 mgkg, or the recommended Phase 3 dose RP3D alongside carboplatin or cisplatin. Carboplatin and cisplatin are also given by intravenous infusion every three weeks, with specific dosing levels. Gemcitabine is administered intravenously on Days 1 and 8 of a 21-day cycle. The study starts with Part A Phase 2 to evaluate activity and safety, followed by Part B Phase 3 to further compare treatments using the dose determined in Part A. During the study, participants will have regular assessments including scans to track tumor response and progression, survival status, and safety monitoring. Researchers will measure overall response rate, progression-free survival, and overall survival over periods up to about 34 to 38 months depending on the phase. The study will also collect tissue samples for biomarker testing. Participants will be closely monitored for side effects and treatment tolerability throughout the trial period.

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.