Hanau

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 evaluating the potential added benefits and safety of a drug called inavolisib when combined with neoadjuvant endocrine therapy for early-stage breast cancer that is HER2-positive, hormone receptor-positive, and has a PIK3CA mutation. This phase II study is open-label, randomized, and conducted at multiple centers. It focuses on how this combination treatment might improve outcomes before surgery in patients with this specific type of breast cancer. Participants will be randomly assigned to one of two treatment groups: one group will receive neoadjuvant endocrine therapy along with a fixed-dose combination of pertuzumab and trastuzumab given by subcutaneous injection every three weeks for six cycles (18 weeks), plus daily inavolisib. The other group will receive the same endocrine therapy and antibody combination without inavolisib. Endocrine therapy options include tamoxifen or an aromatase inhibitor, with or without a GnRH analogue for premenopausal women and men. Treatment continues until surgery or biopsy, disease progression, unacceptable side effects, or patient withdrawal. During the study, patients will undergo surgery or biopsy after completing therapy to assess the rate of complete response in the breast and lymph nodes. Researchers will monitor safety, treatment adherence, and disease status throughout the 21-week treatment period plus a 3-week window. Various tests including cardiac evaluations, laboratory tests, and imaging will be conducted before and during treatment to ensure patient safety and assess the effects of therapy.

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 effectiveness and safety of a combination treatment using pembrolizumab and lenvatinib in women with vulvar cancer that has come back, persisted, spread, or is locally advanced and cannot be treated with surgery or radiation aimed at cure. This is a multicenter, open-label phase II study focusing on patients whose vulvar squamous cell carcinoma cannot be treated with salvage surgery or definitive chemoradiation. The study aims to measure the overall response rate within 24 weeks of treatment. Participants will receive pembrolizumab 400 mg every six weeks and lenvatinib 20 mg daily. The study does not include a comparison group and is designed to monitor the combined treatment's effects in this patient group. Archival or fresh tumor tissue samples will be collected for analysis, and treatment will continue according to the schedule unless safety or disease progression concerns arise. During the study, participants will be closely monitored through tumor assessments, physical exams, and laboratory tests to evaluate treatment response and safety. Researchers will track overall tumor response over 24 weeks and observe any side effects or adverse events. The study requires patients to have adequate organ function and performance status and includes ongoing safety follow-up throughout the treatment period.

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.

This research focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. This research evaluates the effectiveness of upadacitinib (RINVOQ), an approved treatment for UC, in adults with active moderate to severe UC. The study aims to understand the early therapeutic response and predict the long-term effectiveness of this medication. Upadacitinib will be given according to the approved local label and prescribed by the participant's physician as part of routine care. About 400 adult participants from Germany, Austria, and Switzerland who are starting upadacitinib treatment will be enrolled. Treatment decisions are made by the investigator independently of the study. Participants will be followed for up to two years, with no extra procedures beyond their standard care. During the study, participants will attend regular hospital or clinic visits where routine data will be collected and used for the study. Researchers will monitor the percentage of participants achieving symptomatic remission based on clinical response and intestinal ultrasound at week 8, with follow-up assessments at week 52. The study focuses on real-world treatment outcomes without adding extra burden to participants.

Researchers are evaluating the effectiveness and safety of a subcutaneous cladribine treatment for patients with hairy cell leukemia who need therapy. This study focuses on patients who are either untreated or have only been pretreated with alpha-interferon. It aims to assess remission rates four months after treatment and whether a second cycle benefits those with a non-optimal response, defined by residual disease or partial remission. Participants receive cladribine 0.14 mg/kg as a subcutaneous bolus injection once daily for five consecutive days. If the response after the first cycle is not optimal, patients may receive a second cycle of the drug to improve their remission status. This treatment approach is being studied in a Phase 2/3 clinical trial setting. During the study, remission status is evaluated four months after the first treatment cycle. Patients undergo assessments to detect residual disease in bone marrow and peripheral blood. Researchers monitor the rate of complete remissions and any treatment-related toxicities. The overall health, laboratory tests, and disease markers are regularly checked throughout the study period to ensure safety and to measure the treatment's impact.

Researchers are evaluating treatments for hilar cholangiocarcinoma, a bile duct cancer often diagnosed late when surgery is not an option. This study compares two methods used alongside stent placement to keep bile ducts open and kill cancer cells: photodynamic therapy (PDT) and radiofrequency ablation (RFA). PDT involves injecting a photosensitizer absorbed by tumor cells, followed by light application to destroy the cancer. RFA uses heat generated by electrical current delivered through an endoscopic procedure. The study aims to compare overall survival, side effects, and quality of life between these treatments in patients with this cancer. Participants will receive either PDT or RFA during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. For PDT, a photosensitizer is given 24 to 48 hours before light treatment, followed by stent insertion if needed. For RFA, the ablation probe is placed in the tumor area during ERCP, electrical current is applied to destroy cancer cells, and stents are inserted if necessary. Both treatments are performed to relieve bile duct obstruction and target cancer cells locally. During the study, participants will be monitored through clinical assessments and quality of life evaluations. Researchers will track overall survival over about one year and collect data on side effects. Follow-up includes checking stent function and managing any complications. The study includes adults with confirmed hilar cholangiocarcinoma who are not planning surgery and meet other eligibility criteria. Participation involves regular visits to assess treatment outcomes and safety.