Hanau

Researchers are evaluating the potential additional benefits and safety of inavolisib when added to neoadjuvant endocrine therapy for patients with early-stage HER2-positive, HR-positive breast cancer that has a PIK3CA mutation. This phase II study involves patients whose tumors have these specific characteristics and aims to compare the effects of adding inavolisib to a standard treatment regimen. The rationale is to see if inavolisib improves treatment outcomes in this patient group. Participants will be randomly assigned to one of two groups one group will receive neoadjuvant endocrine therapy combined with dual anti-HER2 treatment using a fixed-dose combination of pertuzumab and trastuzumab given subcutaneously every three weeks for six cycles 18 weeks, plus inavolisib taken daily the other group will receive the same endocrine and anti-HER2 therapy without inavolisib. Endocrine therapy may include tamoxifen or an aromatase inhibitor, with or without a GnRH analogue for premenopausal women and men. Treatment continues until surgery, disease progression, unacceptable side effects, or patient withdrawal. After treatment, all patients will undergo surgery or biopsy to assess the complete pathological response. Throughout the study, patients will have physical exams and imaging tests such as sonography, mammography, or MRI to evaluate tumor response. Laboratory tests and cardiac assessments will monitor safety and tolerability. The main outcome measured is the pathologic complete response rate in the breast and lymph nodes approximately 21 weeks after starting treatment. Additional outcomes include safety, response rates, breast conservation rates, and long-term invasive disease-free and overall survival, with follow-up data collected for up to five years. Participation lasts through the treatment period and scheduled assessments.

This research aims to evaluate the effectiveness and safety of combining pembrolizumab with lenvatinib in women with vulvar squamous cell carcinoma VSCC that is recurrent, persistent, metastatic, or locally advanced and cannot be treated with surgery or radiation. This phase II, open-label, single-arm study focuses on patients who have limited treatment options due to the advanced nature of their cancer. Participants receive pembrolizumab 400 mg every six weeks along with daily doses of lenvatinib at 20 mg. The study monitors these treatments over time to assess their combined impact on the disease. This trial does not include a comparison group and follows patients through treatment to observe outcomes. During the study, patients undergo regular evaluations including scans to measure tumor response, lab tests, and assessments of quality of life. Researchers track the overall response rate within 24 weeks as the primary outcome and also evaluate disease control, duration of response, survival rates, and safety throughout treatment and up to 40 months. Adverse events and patient-reported outcomes are closely monitored to understand treatment effects and tolerability.

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

Researchers are conducting a registry study involving adult patients diagnosed with acute myeloid leukemia AML and related myeloid neoplasms, including newly diagnosed or relapsedrefractory cases. The study aims to collect comprehensive data on patient characteristics, family history, biological disease profiles, and clinical outcomes. It also focuses on analyzing disease-related genetic markers and the impact of measurable residual disease MRD using various methods. The study does not involve specific treatments but collects data and biological samples such as bone marrow, blood, plasma, and normal tissue including skin biopsies and other specimens. This observational study enrolls patients from around 80 to 90 sites in Germany and Austria. Patients treatment responses, decisions, and outcomes are tracked over time. Participants are observed for up to 10 years, during which researchers gather information on treatment response, survival, relapse rates, quality of life, and genetic markers. The study includes assessments of event-free survival, relapse-free survival, cumulative incidence of relapse and death, and overall survival. Patient consent is required for registration, data storage, and biobanking of specimens for analysis throughout the observation period.

Researchers are evaluating the effectiveness and safety of a subcutaneous treatment using one cycle of cladribine for patients with hairy cell leukemia who need treatment. This study focuses on patients who are either untreated or have been previously treated only with alpha-interferon. The goal is to determine the rate of complete remission and to assess whether a second cycle of treatment benefits those with a non-optimal response, defined as detectable residual disease or partial remission four months after the initial treatment. Participants receive cladribine at a dose of 0.14 mgkg body weight administered subcutaneously as a bolus injection once daily for five consecutive days. After four months, remission status is evaluated. Patients showing non-optimal response may be considered for a second treatment cycle. This phase 23 trial is designed to optimize therapy for hairy cell leukemia by closely monitoring treatment response and toxicity. During the study, participants undergo evaluations including disease status assessment through bone marrow and blood tests, with a focus on remission rates four months post-treatment. Researchers track complete remission rates and monitor for residual disease. Safety is also monitored by assessing potential toxicities. Participants general health status and other laboratory tests are reviewed to ensure eligibility and ongoing suitability for treatment throughout the study period, which spans several months with follow-up assessments.

This research aims to compare two treatments for patients with hilar cholangiocarcinoma, a type of bile duct cancer often diagnosed late when surgery is not an option. The study evaluates survival outcomes between photodynamic therapy PDT and radiofrequency ablation RFA combined with stent placement, focusing also on side effects and quality of life. These treatments work by killing cancer cells through different methods applied during an endoscopic procedure. All participants will undergo stenting via endoscopic retrograde cholangiopancreatography ERCP to keep bile ducts open. One group will receive at least one PDT session, which involves injecting a photosensitizer absorbed by tumor cells followed by light application to kill the cancer. The other group receives RFA through ERCP, using heat generated by electrical current to destroy cancer cells. Additional stents will be placed if necessary after either treatment. Participants will be monitored for overall survival, stent function, quality of life, and laboratory parameters over about one year, with some measures extending to two years. Assessments include patient-reported itching, blood tests, and evaluations of bile duct status. The study collects data on survival time, hospital days, and quality-adjusted life years to understand treatment impact. Safety and side effects will be followed closely throughout the trial.