Baden Baden

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 recurrence-free survival of women with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary after complete tumor removal. This phase II, randomized, open-label study compares two treatment strategies involving chemotherapy and maintenance therapy with niraparib. The study focuses on patients with no residual tumor mass following primary tumor debulking and aims to determine if fewer cycles of chemotherapy followed by niraparib maintenance are as effective as the standard number of chemotherapy cycles plus niraparib. Participants are randomly assigned to one of two groups: one receiving 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance, and the other receiving 6 cycles of carboplatin plus paclitaxel followed by niraparib maintenance. Randomization is based on genetic analysis and disease stage. Tumor assessments using CT or MRI scans will be done at defined intervals after treatment starts and during maintenance. Blood markers and safety monitoring will be conducted regularly throughout the treatment period. During the study, patients will have clinical visits every 3 weeks during chemotherapy and monthly during the first 11 months of maintenance, then quarterly thereafter. Safety is monitored continuously through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in six European countries over 36 months. The primary outcome measured is recurrence-free survival over 8 years.

Axial spondyloarthritis (axSpA) is an immune-related inflammatory disease mainly affecting the spine, causing chronic back pain and significantly impacting quality of life with symptoms like sleep problems, social isolation, and emotional distress. This research is evaluating the real-world effectiveness of the drug upadacitinib in controlling disease activity and managing pain in adults with active axSpA in Germany. Participants will receive oral upadacitinib tablets as prescribed by their doctors before joining the study, following local guidelines on dosage and treatment. The study will last about 52 weeks, during which participants will continue their prescribed treatment and attend regular medical visits as part of routine care. Throughout the study, researchers will monitor disease activity and treatment effects using medical assessments, side effect checks, and questionnaires. The main focus is on how many participants achieve and maintain low disease activity scores over 24 and 52 weeks, assessing both clinical and patient-reported outcomes related to pain and disease burden.

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 collecting data on patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, a type of blood cancer classified by the WHO in 2008 and 2016. The study aims to register many patients at participating centers to better understand the disease by analyzing biological features and clinical outcomes, including quality of life. The research also focuses on identifying prognostic and predictive markers by correlating disease characteristics with patient results. Participants will be part of a registry study where samples such as bone marrow aspirates, blood, plasma, buccal swabs, and occasionally skin biopsies are collected and stored. Morphologic and genetic analyses will be performed on these samples. There is no intervention treatment; instead, the study gathers extensive clinical and biological data over time to support research. During the study, patients' clinical characteristics, quality of life, and outcome data will be assessed using specific questionnaires and defined clinical variables. Researchers will monitor treatment decisions, response to therapy, survival rates, and progression-free survival for up to 25 years. This long-term follow-up allows comprehensive tracking of the disease course and patient well-being.

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 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 pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under real-world conditions.

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.

Researchers are studying the use of venetoclax in people with chronic lymphocytic leukemia (CLL) to understand how effective it is and to assess the costs and patient-reported outcomes when used in real-life medical settings. The study looks at venetoclax given alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib, based on doctors' decisions and local treatment guidelines. Participants receive venetoclax therapy as prescribed by their physician, which may include the drug alone or along with one of the mentioned combination treatments. The study follows patients in Austria, Germany, and Switzerland, observing how the treatments are used in everyday practice without altering the prescribed therapy. During the study, participants are monitored for up to 12 months to measure the percentage who achieve the best overall response rate (ORR) to treatment. Researchers also collect data on health economics and patient experiences to better understand the impact of these therapies in routine care.