Broomall

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior therapy. This Phase 3 study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate and if it is better regarding progression-free survival, both assessed using standardized disease criteria by independent review. Participants will be randomly assigned to receive one of the three oral treatments: nemtabrutinib, ibrutinib, or acalabrutinib. The study compares the effectiveness of nemtabrutinib against the other two drugs chosen by the investigator to treat first-line CLL/SLL. Treatment continues with monitoring over months to assess response and disease progression. During the study, participants will undergo evaluations based on the International Workshop on Chronic Lymphocytic Leukemia criteria, including blinded independent central reviews of their disease status. Researchers will track objective response rates up to about 33 months and progression-free survival up to around 104 months. Participants will also be monitored for safety and treatment adherence throughout the trial period.

This trial studies participants with relapsed Small Cell Lung Cancer who have received prior treatment. It aims to compare the effectiveness and safety of a new drug called ZL-1310 with therapies chosen by investigators, such as Topotecan, Lurbinectedin, or Amrubicin. This is a Phase 3, randomized, open-label study evaluating outcomes including tumor response rate and overall survival over a period of up to 27 months. Participants receive either ZL-1310 alone or one of the Investigator's Choice therapies as treatment. The study includes screening to confirm measurable disease and eligibility. Treatments are administered according to the study protocol, and tumor biopsies or archived tissue samples are collected at screening. Both treatment groups are monitored for response and side effects throughout the study period. During the trial, participants undergo regular assessments including tumor imaging evaluated by an independent review, and survival status is tracked for up to 27 months. Researchers monitor safety, treatment adherence, and disease progression. Participants are expected to comply with study visits and procedures for the entire duration of the trial to help evaluate the benefits and risks of the treatments.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

Researchers are evaluating a new blood test called Guardant Reveal designed to detect cancer recurrence in people treated for early-stage solid tumors. The study aims to show how well this test can identify cancer returning and link its results to clinical outcomes. This will help understand the test's usefulness in real-world healthcare settings where costs are important. The types of cancers studied include bladder, lung, breast, melanoma, esophageal, gastric, pancreatic, head and neck, ovarian, endometrial, renal, and rectal cancers. Participants will have blood samples taken at the start and during their regular follow-up visits for up to five years. The Guardant Reveal test, which looks for minimal residual disease, will be used to analyze these blood samples to detect any signs of cancer returning. This study includes various groups based on specific tumor types and stages, such as muscle invasive carcinomas, non-small cell lung cancer, high-risk breast cancer, melanoma, gastrointestinal cancers, and others. Each group follows standard care treatments, and the study observes how the new test performs alongside usual monitoring. During the study, participants will provide blood samples coinciding with their routine follow-up care, and their clinical information will be collected and shared with researchers in a de-identified way. The main outcome measured is the time until distant cancer recurrence over three years. The study tracks participants for up to five years to assess the test's ability to detect recurrence early, aiming to improve monitoring and management of these cancers.

Researchers are evaluating the effectiveness of using brain magnetic resonance imaging (MRI) scans alone compared to combining MRI scans with prophylactic cranial irradiation (PCI) in treating patients with small cell lung cancer (SCLC). This phase III trial aims to determine if MRI surveillance alone is not worse than adding PCI in terms of overall survival. The study also looks at cognitive function, brain metastasis-free survival, and treatment side effects among patients with limited or extensive-stage SCLC. Participants are randomly assigned to one of two groups. One group receives PCI, which is radiation therapy focused on the brain, given over two weeks for 20 minutes per day, five days a week, along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group undergoes MRI scans at the same intervals without receiving PCI. Both groups are monitored closely through these MRI scans to track any spread of cancer to the brain. During the study, patients will have regular MRI scans, cognitive assessments, and evaluations of side effects and survival outcomes up to two years after randomization. Blood samples will be collected for future research. Researchers will monitor overall survival, cognitive failure rates, and brain metastasis occurrence, aiming to understand if avoiding PCI might reduce side effects without compromising survival. Participant involvement includes multiple scheduled scans and tests over a two-year follow-up period.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the effectiveness of adding radiation therapy to the usual immune therapy treatment with atezolizumab in people with extensive stage small cell lung cancer that has spread beyond the lungs. This phase II/III trial aims to compare progression-free survival and overall survival between patients receiving atezolizumab alone and those receiving atezolizumab combined with radiation therapy. The study also examines treatment side effects, the effect of radiation on tumor size and number, and the relationship between tumor burden before treatment and patient outcomes. Participants are randomly assigned to one of two groups. One group receives atezolizumab through an intravenous infusion every 21 days. The other group receives the same atezolizumab treatment plus radiation therapy once daily for five days each week over five weeks. During the study, patients undergo various imaging scans including PET/CT, CT, and MRI to monitor their cancer. Blood and tissue samples are also collected. After finishing treatment, patients are followed every three months for two years, then every six months for three years, and annually thereafter. Throughout the trial, researchers assess how long patients live without their cancer worsening and overall survival up to six years after starting treatment. They monitor the safety and side effects of the treatments, using imaging to evaluate tumor response. The study involves regular health exams, scans, and laboratory tests to carefully track each patient's progress and reactions to the therapies over time.