Huntley

Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. This phase III trial aims to determine if durvalumab can improve outcomes such as disease-free survival and overall survival compared to the usual approach of monitoring without additional treatment. The study also assesses quality of life, side effects, and patient-reported symptoms. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously once every 28 days for up to 12 cycles unless the disease progresses or side effects become unacceptable. The other group undergoes active surveillance with regular monitoring. Both groups have computed tomography scans and blood samples collected throughout the 12-month study period. After treatment or observation, patients are followed annually for up to 10 years. Participants will complete questionnaires about their quality of life and symptoms. Researchers will monitor disease recurrence, new lung cancers, and overall survival for up to 10 years. Blood tests and imaging scans will be used to track health status and side effects. Safety and adverse events are evaluated during and after treatment, with long-term follow-up to assess the durability of outcomes.

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.

Researchers are comparing two treatment approaches for patients with high anatomic stage estrogen receptor-positive, HER2-negative breast cancer who have a low risk of the cancer returning. The trial evaluates whether hormone therapy combined with the drug ribociclib works as well as chemotherapy followed by the same hormone therapy with ribociclib. Ribociclib targets enzymes needed for tumor cell growth, and hormone therapy lowers estrogen levels to help stop tumor growth. Chemotherapy works by killing or stopping the division and spread of cancer cells. Participants are first tested with the Oncotype DX assay to assess recurrence risk only those with scores between 0 and 25 continue. They are then randomly assigned to one of two groups one receives standard chemotherapy followed by hormone therapy plus ribociclib, and the other receives hormone therapy plus ribociclib without chemotherapy. Hormone therapy using letrozole, anastrozole, or exemestane is taken daily in 28-day cycles for at least five years, while ribociclib is taken daily for 21 days each cycle for up to three years. Patients undergo scans such as CT, bone scans, or PET-CT and may give blood samples during the study. Participants are followed closely with visits every 3 months during the first year, every 6 months for years 1 to 5, and annually for years 5 to 10. Researchers will assess invasive breast cancer-free survival up to 10 years and compare disease-free survival, recurrence rates, overall survival, and side effects between the two treatment groups. The study also aims to build a biorepository of tumor and blood samples for future research. This trial lasts until 2029, with ongoing monitoring to understand long-term outcomes and safety.