Torgau

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty (PTA) balloon catheters in patients with symptomatic arterial disease affecting the lower limbs. This study includes patients with peripheral artery disease across a range of severity, classified by Rutherford Clinical Categories from 2 to 6, including both claudicants and those with critical limb ischemia. The study is a prospective, multi-center, single-arm post-market clinical follow-up to collect real-world data on these devices. Participants will be treated with one of three AcoArt drug-coated balloon catheters (Orchid, Tulip, or Litos), designed to open narrowed or blocked arteries in the iliac, superficial femoral, popliteal, or infra-popliteal regions. Treatments are performed according to current instructions for use and institutional standard practices. The study follows patients after treatment to continue monitoring the performance and safety of these devices in lower limb revascularization. During the study, patients will undergo protocol-specified examinations and follow-up visits to assess outcomes. Researchers will evaluate primary efficacy and safety endpoints at different time points depending on the severity group, including 30 days, 6 months, and 12 months after treatment. Data collected will include clinical assessments, monitoring for adverse events, and treatment success in improving blood flow and symptoms related to peripheral artery disease.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are evaluating the effectiveness of capivasertib combined with fulvestrant compared to fulvestrant alone as a neoadjuvant treatment for women with primary high-risk lobular breast cancer that is hormone receptor-positive and HER2-negative. This phase II, multicenter, prospective, open-label, randomized study focuses on measuring complete cell cycle arrest (CCCA), defined by a drop in Ki67 below 2.7% from baseline to week 2 and week 10. The study aims to identify patients who may benefit from chemotherapy sparing and to better understand treatment responses in this specific breast cancer subtype. Participants are randomly assigned to receive either capivasertib plus fulvestrant or fulvestrant alone. The capivasertib group takes 400 mg orally twice daily for four days followed by three days off, repeated for two weeks, then continues this dosing alongside fulvestrant injections (500 mg intramuscularly every 28 days, with an additional dose two weeks after the initial) for eight more weeks. The fulvestrant-only group receives the same injection schedule for ten weeks. Treatment continues until surgery or core biopsy, disease progression, unacceptable side effects, or patient withdrawal. All patients undergo core biopsies during treatment to assess Ki67 levels. Following study treatment, further therapies such as surgery, chemotherapy, radiotherapy, or endocrine therapy are given based on standard care and investigator discretion. Participants will have multiple evaluations including core biopsies to monitor Ki67, laboratory tests, and cardiac assessments. Safety and treatment effects are centrally reviewed by a pathologist who is blinded to the treatment assignment. The main outcome measured is complete cell cycle arrest within 14 weeks. Patients are closely monitored for side effects and disease status throughout the study. The total study duration involves treatment for up to ten weeks with follow-up as per standard clinical care.

Researchers are evaluating real-world clinical data in women with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer who are receiving first-line treatment with Carboplatin, Paclitaxel, and Durvalumab (CPD). The study focuses on patients treated with CPD followed by maintenance therapy using either durvalumab alone or durvalumab combined with olaparib. This multi-center, prospective, non-interventional study aims to understand the effectiveness, safety, and patient-reported outcomes of these treatments in routine clinical practice in Germany. Participants receive first-line CPD chemotherapy after surgery and/or radiation if applicable. Following this, maintenance therapy is given with durvalumab for patients with DNA mismatch repair deficient tumors (dMMR cohort) or with durvalumab plus olaparib for those with DNA mismatch repair proficient tumors (pMMR cohort). Treatment decisions are made jointly by patients and their physicians as part of standard care, independent of the study itself. During the study, data on treatment effectiveness and safety will be collected along with patient-reported outcomes after the chemotherapy phase. Researchers will monitor real-world time to the next treatment over 12 months. Patients will complete questionnaires and their tumor mismatch repair status must be known. The study includes women aged 18 years or older and involves regular follow-ups to gather comprehensive information about the treatment effects and patient experience.

Researchers are collecting new real-world data on first-line treatment for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. This study aims to understand how maintenance treatment with Poly ADP ribose polymerase inhibitors (PARPi) affects routine medical care, patient outcomes, and treatment sequences, especially in those undergoing surgery and chemotherapy. It also explores patient-reported experiences, physician insights, genetic testing practices, and drug safety in this setting. The study observes patients receiving first-line platinum-based chemotherapy, including those who have completed primary debulking surgery. It includes patients who have started or are planning to start chemotherapy, with the total number of chemotherapy cycles tailored by the treating physician. Women of childbearing potential must use reliable contraception during the study. The study does not involve any experimental interventions but monitors treatments as they occur in regular clinical practice. Participants will be followed to evaluate progression-free survival and other outcomes up to 84 months from the start of chemotherapy. Patient-reported outcomes will be collected electronically to capture experiences and needs during and after maintenance therapy. The study also tracks the use of BRCA/HRD testing, treatment safety, and physician experiences to better understand care patterns and long-term results in routine clinical settings.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.