Stendal

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 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 collecting data in a registry study for adults diagnosed with acute myeloid leukemia AML, including newly diagnosed and relapsed cases. The study aims to gather important information about the diseases epidemiology, such as patient age and prognostic factors, and to compare incidence and age distribution with population tumor registry data. It also evaluates key clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival. This observational study does not involve treatment assignment but documents treatment strategies used by patients. Data is gathered over a 10-year period to thoroughly monitor outcomes and disease patterns. The registry also collects information on complete remission rates, treatment-related mortality, therapy-associated morbidity, and quality of therapy and diagnosis. Additionally, the study seeks to validate known prognostic factors and explore new ones while describing new therapies and supportive care measures. Participants are adults aged 18 years and older diagnosed with AML according to WHO criteria, including acute promyelocytic leukemia. The study involves long-term follow-up with yearly assessments over 10 years. Researchers will evaluate epidemiological parameters and important survival outcomes. Since this is an observational registry, participants continue with their usual care while data is collected. The study is sponsored by Technische Universitt Dresden and involves multiple sites in Germany.

Researchers are investigating treatments for triple-negative breast cancer TNBC, a type of breast cancer known for its aggressive nature, poor outlook, and diverse molecular features. The study focuses on patients with lower-risk, early-stage TNBC, where current chemotherapy standards exist but optimal treatment strategies and durations remain unclear. This trial aims to compare neoadjuvant therapies to improve outcomes in this common patient group, addressing a significant medical need in Western Europe and the USA. The trial compares two neoadjuvant treatment options sacituzumab govitecan SG alone versus SG combined with pembrolizumab PEM. Both treatments are given intravenously over 12 weeks in four cycles. Depending on the patients response after 12 weeks, some may receive additional cycles before surgery. After surgery, further treatment depends on the pathological response, with some patients receiving chemotherapy if residual cancer remains. The study evaluates if these regimens can achieve high rates of complete remission with a better safety profile compared to standard chemotherapy. Participants will undergo regular clinical assessments, including pathology reviews and imaging, throughout treatment and follow-up. Researchers will monitor responses at surgery, invasive disease-free survival up to three years, and overall survival over six years. Quality of life is also assessed through questionnaires during and after treatment. The trial involves careful safety monitoring and long-term follow-up to understand the effects of these therapies on disease recurrence and patient well-being.

Researchers are investigating the best timing for radiotherapy in women with high-risk breast cancer who have received neoadjuvant chemotherapy. The study compares preoperative radiotherapy to the standard postoperative radiotherapy to see if it improves disease-free survival and reduces radiation-related late side effects. This is a randomized phase III trial conducted internationally to address an important gap in breast cancer treatment. Participants are randomly assigned to receive either radiotherapy before surgery or the usual radiotherapy after surgery. Both treatments include radiation to the whole breast or chest wall, with additional boosts to the tumor bed when breast-conserving surgery is performed. If lymph nodes are involved, radiation to regional lymph nodes is also given. Treatments follow national and international guidelines and are carefully monitored. Throughout the study, participants will be followed for 6 to 10 years to assess disease-free survival as the main outcome. Researchers will also track local and regional recurrences, metastasis-free survival, overall and disease-specific survival, cosmetic results, quality of life, arm lymphedema, brachial plexus toxicity, and other treatment-related side effects. Regular evaluations by physicians and patient questionnaires will help monitor safety and effectiveness over the long term.

Researchers are collecting real-world data on first-line treatment of newly diagnosed advanced high-grade epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer, in Germany. This observational study aims to better understand the effects of initial treatments such as surgery, chemotherapy, and maintenance therapies, with a focus on how PARP inhibitor maintenance influences outcomes for patients, doctors, and healthcare payers. It also examines testing behaviors for BRCA and HRD mutations, treatment choices, safety, and sequences in case of cancer recurrence. The study observes three groups of patients based on their maintenance therapy after first-line platinum-based chemotherapy those receiving PARP inhibitor maintenance, those continuing bevacizumab maintenance without PARP inhibitors, and those who do not receive any maintenance treatment. Patients eligible for primary debulking surgery must have completed surgery before joining, and those undergoing neoadjuvant chemotherapy are enrolled after surgery and prior to the first post-surgery chemotherapy cycle. The study captures routine clinical care without assigning treatments. Participants will be followed for up to 84 months to record progression-free survival, recurrence, subsequent therapies, overall survival, and patient-reported quality of life using various questionnaires. Data on treatment effects, patient experiences, and physician practices will be collected during and after maintenance therapy and through recurrence. This long-term observation seeks to provide insights into treatment outcomes and patient well-being in routine medical practice.

Researchers are evaluating the safety and effectiveness of a radio frequency renal denervation system to treat patients with uncontrolled hypertension. This international, multi-center, randomized clinical trial compares two methods of accessing the renal artery radial access and femoral access. The study focuses on patients who continue to have high blood pressure despite taking multiple antihypertensive medications, including angiotensin receptor blockers or ACE inhibitors combined with diuretics or calcium channel blockers. Participants will be randomly assigned to one of two groups. One group will receive the renal denervation procedure through the radial artery wrist, and the other through the femoral artery groin, both using the Iberis Renal Denervation System. Around 90 patients will be enrolled from about 12 sites across three European countries. The study includes follow-up visits at 3 and 6 months after treatment to monitor outcomes and safety. During the study, patients will have their blood pressure measured in the office, at home, and by ambulatory monitoring. Researchers will also track procedural details, vascular complications, heart rate, renal function, medication changes, and patient satisfaction. Safety assessments include monitoring vascular access site complications, stroke or transient ischemic attacks, and bleeding events. The total duration of the study is approximately 38 months with about 27 months planned for patient enrollment.