Worms

Researchers are studying the real-world effectiveness, safety, and patient experience of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months 5 years. The study allows prior use of CDK46 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patients randomization.

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.

This research aims to evaluate whether the medicine vicadrostat, combined with empagliflozin, helps adults who have chronic heart failure with a weakened heart pumping function, defined by a left ventricular ejection fraction under 40. Participants must have been diagnosed with chronic heart failure for at least three months and have symptoms classified as New York Heart Association class II to IV. The study is a Phase III trial conducted by Boehringer Ingelheim to assess the efficacy and safety of these medicines compared to placebo with empagliflozin. Participants are randomly assigned to one of two groups one group receives vicadrostat plus empagliflozin tablets, and the other group receives placebo tablets plus empagliflozin. Tablets are taken once daily for a period ranging from about six months up to approximately three and a half years. Participants continue their usual heart failure treatments during the study. The trial includes regular study visits and phone contacts to monitor health and treatment effects. During the study, participants will have their health regularly checked, including monitoring for worsening heart failure symptoms, hospitalizations, or death related to heart failure. They will also complete questionnaires about their well-being. The main measure is the time until the first cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. Researchers will compare these outcomes between treatment groups to see if the combined treatment affects these events. Safety and any unwanted effects will be closely tracked throughout the study period, which can last up to about 3.5 years.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups one receiving standard endocrine therapy chosen by the doctor including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patients randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

Researchers are evaluating the effect of adding capivasertib to fulvestrant compared with fulvestrant alone as neoadjuvant treatment for women with primary high-risk lobular breast cancer that is hormone receptor positive and HER2 negative. This phase II, open-label, randomized study focuses on measuring the complete cell cycle arrest CCCA by assessing Ki67 levels at baseline, week 2, and week 10. The study aims to identify patients who may benefit from combined treatment and potentially avoid chemotherapy, considering the unique characteristics of invasive lobular breast cancer. Participants are randomly assigned to one of two treatment groups. One group receives capivasertib orally twice daily for 4 days followed by a 3-day break for 2 weeks, then continues this capivasertib schedule combined with fulvestrant injections every 28 days for an additional 8 weeks, totaling four doses of fulvestrant. The other group receives fulvestrant injections alone on the same schedule for 10 weeks. Treatment continues until surgery, disease progression, unacceptable side effects, or patient withdrawal. During the study, all patients will undergo core biopsies before and after treatment to measure Ki67 levels. Researchers will assess safety, pathological response, breast conservation rates, and survival outcomes. Patients will be monitored throughout treatment and follow-up, which may last up to two years to assess invasive disease-free survival and overall survival. Additional therapies such as surgery, chemotherapy, or radiotherapy will be given as needed outside the trial according to standard care.

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 studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating a treatment for advanced breast cancer that is estrogen receptor-positive, HER2-negative, and has a specific ESR1 gene mutation. The study aims to find out how well a combination of elacestrant, a selective estrogen receptor degrader, and everolimus, a kinase inhibitor, works in patients whose cancer has progressed despite prior endocrine therapy and CDK46 inhibitor treatment. The study follows strict guidelines to ensure patient safety and compliance with international clinical standards. Participants will be randomly assigned to one of two groups. One group will receive elacestrant at 345 mg plus everolimus at 7.5 mg orally once daily, while the other group will receive elacestrant at the same dose plus a placebo instead of everolimus. Treatments will be given in 28-day cycles and continue until disease progression, unacceptable side effects, or other reasons for stopping the treatment occur. After stopping treatment, patients will be followed every three months for up to one year to monitor survival and any new cancer therapies. During the study, patients will undergo scans such as CT or MRI to confirm disease status, and tests to assess tumor markers and gene mutations. Researchers will monitor treatment effects, safety, and quality of life using questionnaires like the EQ-5D-5L and EORTC QLQ-C30 and QLQ-BR42. Side effects, blood counts, liver and kidney function, heart activity, and overall health status will be regularly checked. The main outcome is progression-free survival, measuring how long patients live without cancer worsening during treatment, with other outcomes including overall survival and treatment response. The total study duration for each participant averages about 12 months.