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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

Age: 18Years +All GendersPhase 3
963 locations
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Actively Recruiting

Researchers are evaluating how well osimertinib works in treating patients with advanced non-small cell lung cancer NSCLC that has a specific EGFR exon 20 insertion mutation. This includes patients with stage IIIB-IV disease or those whose cancer has returned after improvement. The study is a phase II trial aiming to understand the tumor response and safety profile of osimertinib in this group. Researchers also want to explore molecular and genetic markers related to treatment response and resistance. Participants receive osimertinib orally once daily in 21-day cycles, continuing until the cancer worsens or side effects become unacceptable. During treatment, patients have imaging tests like echocardiography or MUGA scans, MRI or CT scans with contrast, and blood samples collected to monitor their health and disease. After stopping treatment, patients are followed for 30 days and then every three months for up to five years to assess long-term outcomes. Throughout the study, researchers measure the best tumor response, progression-free survival, overall survival, and any side effects experienced. They also analyze blood and tumor samples to study molecular markers and resistance mechanisms. The total participation can last up to five years, including treatment and follow-up periods, with regular imaging and laboratory assessments to track the disease and patient safety.

Age: 18Years +All GendersPhase 2
344 locations