Stendal

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 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 collecting data in a registry study focused on adults with newly diagnosed or relapsed acute myeloid leukemia (AML). The study aims to gather detailed epidemiological information such as age, prognostic factors, and subgroup distributions. It also compares AML incidence and age distribution with population-based tumor registry data. Important clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival are being evaluated over a 10-year period. This study does not involve experimental treatments but instead documents current treatment strategies used in AML patients. Data collection occurs at 60 investigator sites across Germany, providing a broad overview of patient characteristics and management. There is no upper age limit, and all adult patients diagnosed according to WHO criteria, including acute promyelocytic leukemia, are eligible. Participants will be followed for up to 10 years, during which epidemiological parameters and survival outcomes will be monitored. Researchers will record relapse events, time until relapse, and survival status to understand long-term outcomes. This extensive follow-up intends to support improved knowledge about AML patient prognoses and treatment impacts over time.

Researchers are investigating treatments for triple-negative breast cancer (TNBC), a type of breast cancer known for its aggressive nature, poor prognosis, and diverse molecular characteristics. This study focuses on patients with early-stage, lower-risk TNBC, particularly those with stage I-II node-negative disease, who generally have better outcomes but still face significant clinical challenges. The trial aims to compare the effects of sacituzumab govitecan alone versus sacituzumab govitecan combined with pembrolizumab in this patient group, seeking to improve treatment responses and survival rates. Participants will receive sacituzumab govitecan at a dose of 10 mg/kg administered twice on days 1 and 8 within a 21-day cycle. Some participants will also receive pembrolizumab at 200 mg every three weeks. The study evaluates treatment durations between 12 and 18 weeks in the neoadjuvant (pre-surgery) setting. The purpose is to assess whether these regimens can produce comparable pathological complete remission rates with a better safety profile compared to standard chemotherapy. The combination with pembrolizumab is explored based on promising results in more advanced TNBC stages. Throughout the study, participants will undergo various assessments including imaging, pathology reviews, and laboratory tests to monitor tumor response and overall health. The primary outcomes measured are pathological complete remission at surgery and invasive disease-free survival rate after three years. Safety and tolerability will also be closely observed. Participants must comply with treatment schedules and follow-ups, providing consent and cooperating with all protocol requirements during the study period.

Researchers are evaluating the timing of radiotherapy for women with high-risk breast cancer who have already received neoadjuvant chemotherapy (NACT). This phase III international trial compares whether giving radiotherapy before surgery (preoperative) leads to better disease-free survival (DFS) and fewer late radiation side effects compared to the standard approach of radiotherapy after surgery (postoperative). The study aims to find the best timing for radiotherapy to prevent cancer recurrence and improve survival outcomes. Participants will receive either preoperative radiotherapy or postoperative radiotherapy after completing neoadjuvant chemotherapy and surgery. Radiotherapy may target the whole breast or chest wall and, if lymph nodes are involved, the regional lymph nodes as well. The treatment approach follows established guidelines and includes the possibility of an additional radiation boost to the tumor bed in breast-conserving therapy. During the study, participants will be monitored for disease-free survival over 6 to 10 years. Researchers will assess cancer recurrence, survival, and radiation-related late effects. Patients will undergo regular evaluations including clinical assessments and imaging as needed to follow their health status. The trial requires informed consent and includes safety monitoring throughout the long-term follow-up period.

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 evaluating the safety and effectiveness of radiofrequency renal denervation using the Iberis Renal Denervation System in patients with uncontrolled hypertension. This international, multi-center, randomized clinical trial compares two access methods for the procedure: radial artery access and femoral artery access. The study includes 90 patients who have uncontrolled high blood pressure despite taking 2 to 5 antihypertensive medications, including specific drug combinations. Participants will be randomly assigned to receive renal denervation either through radial artery access or femoral artery access. The procedure involves using radiofrequency energy to treat the renal arteries via the Iberis system. Patients will be followed according to standard care, with study visits scheduled at 3 months and 6 months after treatment. A parallel registry will include patients who cannot undergo femoral access due to certain conditions, but only those eligible for femoral access are included in this trial. Throughout the study, researchers will measure changes in office systolic blood pressure at 3 months as a primary outcome. Patients will have multiple blood pressure assessments and follow-up visits within specified time windows. The total study duration is estimated to be 38 months, with enrollment lasting about 27 months. Safety and efficacy are monitored through these visits and standard care practices.