Torgau

Researchers are evaluating the real-world effectiveness, safety, and patient compliance 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 ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty PTA balloon catheters in patients with symptomatic peripheral artery disease undergoing lower limb revascularization. This observational study includes patients with varying severity of arterial disease, classified by Rutherford Clinical Categories 2-6, to monitor real-world outcomes following standard treatment practices. Participants will receive treatment using one of three types of AcoArt drug-coated PTA balloon cathetersOrchid, Tulip, or Litosdesigned for arteries in the lower limbs. The study is a single-arm, multi-center follow-up that observes outcomes without altering usual care, focusing on two patient groups those with moderate symptoms Rutherford 2-3 and those with critical limb ischemia Rutherford 4-6. Throughout the study, participants will undergo various assessments to track safety and treatment effectiveness at multiple time points, including 30 days, 6 months, 12 months, and up to 60 months. Researchers will collect data on clinical improvements, wound healing, need for additional procedures, survival rates, and amputation rates. Patients are expected to attend follow-up visits and comply with study protocols for monitoring and data collection during this extended observation period.

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 gathering real-world clinical data from women with primary advanced FIGO stage III or IV or recurrent endometrial cancer who are treated with first-line chemotherapy regimens combining Carboplatin, Paclitaxel, and Durvalumab CPD. This observational study focuses on patients receiving maintenance therapy with durvalumab alone or durvalumab combined with olaparib, depending on their tumors DNA mismatch repair status. The aim is to evaluate treatment outcomes including effectiveness, safety, and patient-reported experiences after chemotherapy. Participants receive first-line CPD chemotherapy followed by maintenance therapy tailored to their tumor characteristics patients with DNA mismatch repair deficient tumors receive durvalumab maintenance, while those with proficient status receive both durvalumab and olaparib maintenance. Treatment decisions are made as part of routine care in collaboration with their doctors, independent of the study. The study observes patients who achieve disease control after chemotherapy, tracking their ongoing treatments according to approved guidelines. During the study, participants complete questionnaires to report their quality of life and health status over time. Researchers monitor time to next treatment and progression-free survival at 12 months, as well as the duration of maintenance therapy and chemotherapy phases, and timing between treatments. Safety and real-world usage of therapies are assessed up to 46 months. The study spans multiple centers in Germany and aims to better understand characteristics of patients benefiting from these treatments in everyday clinical practice.

Researchers are evaluating the effectiveness and safety of palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with advanced breast cancer that is estrogen receptor positive ER and human epidermal growth factor receptor 2 negative HER2-. This phase 3 clinical trial includes women and men who have not yet received systemic treatment for their advanced breast cancer, aiming to find improved first-line treatment options. Participants are randomly assigned to one of two groups one group receives palazestrant 90 mg daily with ribociclib 600 mg daily taken on days 1-21 of each 28-day cycle plus a placebo matching letrozole the other group receives letrozole 2.5 mg daily with ribociclib 600 mg daily plus a placebo matching palazestrant. Treatments are given in repeating 28-day cycles. The study is double-blind and active-controlled, meaning neither participants nor researchers know who receives which treatment, and both groups receive active drugs. During the trial, participants will be monitored regularly for disease progression and survival over approximately 3.5 to 5.5 years. Assessments include tumor response evaluations, safety and tolerability checks, pharmacokinetic blood tests every 28 days, and patient-reported health outcomes. The primary outcome is progression-free survival, measuring the time from randomization until disease worsens or death. Safety monitoring continues for up to 42 days after treatment ends, with the study lasting until 2032.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.

Researchers are observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.