Thonon Les Bains

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 whether using a genetic test called Prosigna4 can help decide if chemotherapy is necessary for premenopausal women with hormone receptor-positive HR and HER2-negative breast cancer. This study aims to determine if treatment guided by this test produces similar outcomes to the standard approach of systematic chemotherapy. The trial focuses on younger women who often experience more side effects from chemotherapy, affecting their quality of life and work capacity. Participants will be randomly assigned to one of two groups. In the experimental group, treatment depends on the Prosigna4 score women with a high score above 60 will receive chemotherapy plus hormone therapy, while those with a lower score will receive only hormone therapy with ovarian suppression. The control group will receive the standard treatment of chemotherapy followed by hormone therapy. The study includes a pre-inclusion period for eligibility testing and randomization. Throughout the study, participants will complete questionnaires about quality of life, treatment side effects, emotional well-being, and other health measures for up to five years after randomization. Researchers will monitor cancer recurrence, survival, fertility, osteoporosis, cardiovascular disease, and other outcomes. Regular assessments include physical activity levels, adherence to therapy, and patient perceptions of treatment and participation, aiming to evaluate the safety and impact of treatment guided by the genetic test.

Researchers are evaluating the effectiveness and safety of two combination treatments for adults with hormone receptor positive HR, human epidermal growth factor receptor 2 negative HER2- locally advanced or metastatic breast cancer that has a PIK3CA mutation. These patients have experienced recurrence or progression after treatment with a CDK46 inhibitor. This Phase 3, open-label, randomized study compares RLY-2608 zovegalisib plus fulvestrant against capivasertib plus fulvestrant to determine which treatment better controls the disease. Participants are assigned to one of two groups one group receives zovegalisib orally twice daily along with fulvestrant administered by injection on specific days during a 28-day treatment cycle the other group receives capivasertib orally twice daily on an intermittent weekly schedule plus fulvestrant injections on the same schedule. Treatment cycles repeat every 28 days. The study is conducted globally at multiple centers and continues until disease progression or other criteria are met. During the study, participants undergo regular assessments including scans reviewed by blinded independent central review to measure progression-free survival, as well as monitoring overall survival, response rates, quality of life questionnaires, and safety evaluations. Blood samples are taken periodically to measure drug levels. The study may last up to approximately 77 months for outcome measurements, with ongoing monitoring for adverse events and quality of life changes throughout this period.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

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.

This research aims to observe patients in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.

This trial investigates whether postmenopausal women aged 60 and older with early-stage, low-risk hormone receptor-positive breast cancer can safely avoid hormone therapy after surgery without increasing the risk of cancer relapse. The study focuses on women with small, low-grade tumors classified as Luminal A subtype, which generally have an excellent prognosis and low recurrence rates. Researchers aim to better understand the balance of treatment benefits and side effects, especially considering the long-term burden of hormone therapy on quality of life. Participants will not receive the standard hormone therapy such as tamoxifen or aromatase inhibitors during the study. All participants will have undergone surgery and possibly radiation therapy prior to enrollment. This study enrolls participants for two years and compares their outcomes to historical data from patients who received hormone therapy, assessing cancer recurrence and health outcomes over time. During the trial, participants will be monitored for up to five years after the last enrollment to track relapse-free survival, incidence of new breast cancer events, distant disease-free survival, overall survival, and quality of life. Evaluations will include questionnaires on quality of life, anxiety, and depression, as well as monitoring for bone health, cardiovascular events, and other treatment-related conditions. The study aims to provide evidence for more personalized treatment approaches and to improve shared decision-making for women with low-risk breast cancer.

Researchers are studying the effects of acetylsalicylic acid and atorvastatin on overall survival in patients with castrate-resistant prostate cancer CRPC who are starting first-line treatment. This international, open, phase III trial uses a 2x2 factorial randomized design to evaluate these drugs in addition to the standard care for CRPC. The study aims to understand whether adding these medications can improve survival outcomes for this patient group. Participants are randomly assigned to one of four groups standard of care alone, standard of care plus acetylsalicylic acid 100 mg daily, standard of care plus atorvastatin 80 mg daily, or standard of care plus both acetylsalicylic acid and atorvastatin. These treatments are taken daily alongside the usual care for their cancer. The trial monitors patients over up to 15 years to assess the long-term impact on survival. During the study, participants will be regularly evaluated for overall survival, which is calculated from the date of randomization until death. Researchers will also monitor patients for safety and adherence to the treatments. The trial includes detailed eligibility screening, performance status assessments, and laboratory tests to ensure patients meet the criteria to participate safely. The long follow-up period allows for comprehensive observation of treatment effects and patient outcomes.

Researchers are evaluating a new chemotherapy dosing approach in women with poor prognostic ovarian cancers who have unfavorable primary chemosensitivity and incomplete debulking surgery. This phase III trial compares a salvage weekly dose-dense chemotherapy regimen to continuing the standard chemotherapy regimen, aiming to confirm if adjusting the dose and schedule improves outcomes. The study is pragmatic and open-label, reflecting routine clinical practice in a real-world patient population. Participants are randomly assigned to one of two groups an experimental arm receiving a intensified chemotherapy schedule with carboplatin and paclitaxel given weekly in 3-week cycles for three cycles, optionally combined with daily subcutaneous GCSF injections or a standard arm continuing the same 3-weekly carboplatin-paclitaxel regimen used during initial treatment, with optional GCSF support. Randomization accounts for factors like bevacizumab use, BRCA mutation status, and KELIM score subgroup. The treatment period focuses on this chemotherapy phase. During the trial, participants will be monitored for surgery outcomes, overall and progression-free survival, tumor response, and adverse events. Assessments include clinical evaluations and imaging based on RECIST criteria, with follow-up extending up to five years for survival analysis. Researchers will also evaluate the impact of additional treatments like PARP inhibitors and bevacizumab on patient outcomes. The total study duration covers treatment and long-term monitoring of efficacy and safety measures.