Meriden

Researchers are evaluating whether adding adjuvant chemotherapy ACT to ovarian function suppression OFS plus endocrine therapy ET improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigators discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients health and quality of life.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

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. The trial aims to determine if durvalumab can improve disease-free survival and overall outcomes compared to the usual approach of monitoring without additional treatment. This is a phase III randomized trial focusing on patients with stage II-IIIB non-small cell lung cancer who achieved a complete response after neoadjuvant chemo-immunotherapy. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously every 28 days for up to 12 cycles, pending no disease progression or unacceptable side effects. The other group undergoes active surveillance through regular follow-up without additional treatment for 12 months. Both groups have scheduled computed tomography scans and blood sample collections throughout the trial. Patients are followed annually for up to 10 years after treatment completion. During the study, participants undergo various assessments including CT scans, blood tests, and patient-reported quality of life questionnaires. Researchers monitor disease recurrence, new lung cancers, survival, and treatment side effects over a 10-year period. Quality of life and symptom evaluations related to skin and nerve sensations are also compared between the groups. This extensive follow-up helps evaluate the long-term effects and safety of durvalumab versus observation.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the effects of two chemotherapy combinations, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for treating advanced, unresectable, or metastatic HER2 negative cancers of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine if overall survival improves with mFOLFIRINOX compared to mFOLFOX and to assess differences in progression-free survival, response rates, safety, and patient-reported outcomes. Participants are randomly assigned to one of two groups one receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan intravenously, with nivolumab given as needed the other group receives fluorouracil, leucovorin calcium, and oxaliplatin intravenously, also with nivolumab as indicated. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional research on markers like PD-L1 combined positive score and cell-free DNA. During the study, participants will have regular imaging scans and blood collections to monitor their cancer and treatment effects. Researchers will track overall survival for up to two years and monitor progression-free survival, tumor response, duration of response, and adverse events for up to three years. Patient-reported outcomes will be collected at baseline and throughout treatment cycles to assess tolerability and side effects.

Researchers are evaluating the combination of bevacizumab and osimertinib versus osimertinib alone as an initial treatment for patients with advanced non-small cell lung cancer NSCLC that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial aims to understand if adding bevacizumab, which inhibits blood vessel growth to tumors, can control cancer longer and improve survival compared to osimertinib alone, which blocks EGFR involved in tumor cell growth. Participants are randomly assigned to one of two groups. One group receives daily oral osimertinib every 21 days, while the other group receives the same osimertinib dose plus an intravenous bevacizumab infusion every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients undergo various imaging tests such as echocardiography, multigated acquisition scan, computed tomography, and possibly magnetic resonance imaging, along with blood and urine sample collections. After treatment ends, patients are followed every three months for up to 10 years to monitor their health and disease status. The main outcome measured is progression-free survival, tracking the time until the cancer worsens or death occurs. Secondary outcomes include overall survival, response rates, and effects on central nervous system progression. Safety is also assessed through adverse event monitoring. This long-term follow-up helps researchers understand the lasting effects of the treatments.

Researchers are evaluating whether observation alone is as effective as continuing treatment with pembrolizumab in preventing cancer recurrence in patients with early-stage triple-negative breast cancer TNBC who achieved a complete response after receiving chemotherapy combined with pembrolizumab before surgery. This phase III trial aims to compare these approaches in terms of recurrence-free survival, quality of life, and overall value of care. The study also examines side effects, survival rates, and financial impacts associated with the treatments. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab treatment intravenously every 3 or 6 weeks for 27 weeks, while the other group undergoes observation without additional treatment during this period. Both groups will have tumor biopsies and blood samples collected, along with imaging tests like mammography, breast ultrasound, or MRI during follow-up. Throughout the study, participants will be monitored for cancer recurrence, survival, adverse events, and quality of life using questionnaires and assessments. Blood and tumor samples will help track biological markers. The primary outcome is recurrence-free survival over up to 10 years. Secondary outcomes include adverse event rates, overall survival, and local recurrence. Additional evaluations cover financial costs, work productivity, and patient-reported side effects. The total participation may involve long-term follow-up and several assessments over approximately 27 weeks and beyond.

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 investigating targeted therapies approved by the Food and Drug Administration FDA for patients with advanced cancers that have specific genetic changes. This study, called the Targeted Agent and Profiling Utilization Registry TAPUR Study, aims to understand how safely and effectively these targeted drugs work when prescribed in real-world settings for cancers with actionable genomic variants. The study also collects data on molecular testing choices and helps generate ideas for future clinical trials. Participants receive one of several FDA-approved targeted anticancer drugs, chosen based on specific genetic features of their tumors. These drugs include palbociclib, sunitinib, temsirolimus, trastuzumab with pertuzumab, vemurafenib with cobimetinib, regorafenib, olaparib, nivolumab with ipilimumab, abemaciclib, talazoparib, atezolizumab with talazoparib, tucatinib with trastuzumab, futibatinib, dabrafenib with trametinib, and fam-trastuzumab deruxtecan-nxki. Each treatment follows the approved dosing schedule and duration. Different genetic alterations qualify patients for different drugs, and the study covers a wide range of tumor types, including advanced solid tumors, multiple myeloma, and non-Hodgkin lymphoma. During the study, participants undergo regular assessments including physical exams and imaging tests to measure tumor response using standard criteria. The main outcome measured is the percentage of patients with tumor shrinkage or stable disease after 16 weeks of treatment. Researchers also monitor overall survival for up to three years. Safety and organ function are closely tracked through laboratory tests. Participants must provide informed consent and meet specific eligibility criteria, including measurable disease and acceptable organ function. The study does not use random assignment, and results are shared publicly as they become available and at study completion.

Researchers are evaluating the addition of tivozanib to the immunotherapy drug pembrolizumab compared to pembrolizumab alone for patients with high-risk renal cell carcinoma RCC. This phase III trial aims to assess whether combining these treatments improves disease-free survival and overall survival in patients who have undergone surgery to remove all known kidney cancer sites. The study also looks at side effects, quality of life, fatigue, and collects specimens for future research. Participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days within a 12-week cycle, repeated up to four cycles if no disease progression or unacceptable side effects occur. The other group receives the same pembrolizumab schedule plus oral tivozanib taken daily on specified days within the cycle for up to six months. Both groups have blood samples taken and undergo MRI or CT scans during the trial. Tissue biopsies may also be performed. After the treatment phase, participants are followed with check-ups every four months for two years, then every six months for three years, and then yearly for five more years. Researchers monitor disease recurrence, survival, side effects, treatment tolerance, and patient-reported quality of life and fatigue through questionnaires. This long-term follow-up helps evaluate the lasting effects and safety of the treatments.