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Researchers are studying women with a newly diagnosed invasive breast cancer that is node negative and 3 cm or smaller in size to compare two types of radiation therapy after breast-conserving surgery BCS. The study aims to see if partial breast irradiation PBI given once daily over one week is not worse than whole breast irradiation WBI in preventing cancer return and whether it results in better cosmetic outcomes. This is a randomized, single-blind trial focusing on local recurrence and patient-assessed cosmesis three years after treatment. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total of 26 Gy radiation in 5 fractions, given once daily over 5 to 7 days with up to 8 days allowed for scheduling reasons. PBI targets the tumor bed plus a margin of normal tissue, while WBI targets the whole breast. Patients will not know which treatment they receive to avoid bias in cosmetic assessments. Stratification factors include tumor size, estrogen receptor status, and clinical center. During the study, participants will be monitored for local recurrence annually for five years and will assess their cosmetic outcome at three and five years post-treatment. Researchers will also evaluate survival, disease-free survival, radiation side effects, and quality of life at various intervals. Clinical assessments and nurse evaluations of cosmesis will occur at three and five years. Overall, participant involvement spans several years with multiple follow-up visits to measure outcomes and safety.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating the safety and preliminary effectiveness of DB-1311 combined with BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, open-label, multicenter trial includes participants with various cancers such as hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic ductal carcinoma, breast cancer, colorectal cancer, and metastatic castration-resistant prostate cancer. The trial involves escalating doses of the drug combinations DB-1311BNT324 with either BNT327 or DB-1305BNT325. These treatments are given intravenously to define recommended phase 2 doses in different patient groups. Participants are assigned to one of several study arms based on their cancer type and dose level, with treatment continuing as per protocol. The study aims to establish safe dosing and observe treatment responses over time. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events up to 72 months. The study will measure tumor response using RECIST 1.1 criteria and evaluate overall survival, progression-free survival, and other outcomes. Blood samples will be collected to study drug concentrations and immune responses. The trial includes follow-up visits to monitor safety and effectiveness throughout the study duration.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the long-term safety of nivolumab alone or in combination with other cancer therapies in patients with various tumor types. This Phase 2 study focuses on monitoring the effects and side effects of these treatments over an extended period to understand their safety profiles better. Participants receive one of several treatment regimens involving drugs such as nivolumab, ipilimumab, cabozantinib, trametinib, relatlimab, and others. Each treatment is given at specified doses on set days, with some regimens combining multiple drugs. The study includes patients who have previously participated in Bristol-Myers Squibb sponsored trials and may continue or restart treatment based on prior response. Throughout the study, participants undergo regular safety assessments to track adverse events, including serious, immune-mediated, and drug-related side effects. Monitoring continues from the first day of treatment up to 135 days after stopping treatment to assess the incidence of adverse events and deaths. This comprehensive safety monitoring helps researchers understand the long-term effects of these cancer therapies over several years.

Researchers are evaluating the effectiveness and safety of two combination treatments for adults with hormone receptor positive HR, human epidermal growth factor receptor 2 negative HER2- locally advanced or metastatic breast cancer that has a PIK3CA mutation. These patients have experienced recurrence or progression after treatment with a CDK46 inhibitor. This Phase 3, open-label, randomized study compares RLY-2608 zovegalisib plus fulvestrant against capivasertib plus fulvestrant to determine which treatment better controls the disease. Participants are assigned to one of two groups one group receives zovegalisib orally twice daily along with fulvestrant administered by injection on specific days during a 28-day treatment cycle the other group receives capivasertib orally twice daily on an intermittent weekly schedule plus fulvestrant injections on the same schedule. Treatment cycles repeat every 28 days. The study is conducted globally at multiple centers and continues until disease progression or other criteria are met. During the study, participants undergo regular assessments including scans reviewed by blinded independent central review to measure progression-free survival, as well as monitoring overall survival, response rates, quality of life questionnaires, and safety evaluations. Blood samples are taken periodically to measure drug levels. The study may last up to approximately 77 months for outcome measurements, with ongoing monitoring for adverse events and quality of life changes throughout this period.

Researchers are studying whether Magnetic Resonance Imaging MRI results can help identify women with early breast cancer who might safely skip radiotherapy after surgery without increasing the chance of cancer returning in the same breast. This international follow-up study, called PROSPECTIVE, builds on earlier research suggesting that MRI combined with pathology can select patients with low-risk breast cancer who may not need radiotherapy. The study also looks at patient quality of life, fear of cancer recurrence, and health economics related to omitting radiotherapy. Participants are divided into two groups based on their MRI and pathology results before surgery. Those with minimal or mild breast changes on MRI and meeting certain pathology criteria may be assigned to Arm A, where radiotherapy is omitted. Arm A is further divided into low-risk and high-risk groups based on cancer grade and HER2 status. Participants not meeting these criteria, or those preferring standard care, receive radiotherapy as part of Arm B. Treatment decisions consider MRI findings, pathology details, and patient or clinical team preferences. During the study, participants undergo regular follow-up for up to 10 years to monitor if cancer returns in the same breast or elsewhere. Researchers assess outcomes including invasive recurrence rates, quality of life, fear of recurrence, mental health, and survival. Patient-reported outcomes are collected at multiple timepoints up to five years post-surgery. The long-term follow-up helps evaluate the safety and impact of omitting radiotherapy in selected patients with early breast cancer.

This research aims to evaluate the omission of adjuvant whole breast radiation therapy in women with breast cancer who have no clinical evidence of lymph node involvement and have achieved a pathological complete response after neoadjuvant chemotherapy. The study focuses on female patients with newly diagnosed T1-3 node negative breast cancer treated with breast conserving surgery and axillary staging surgery, without distant metastatic disease. The goal is to understand the impact of skipping radiation therapy on breast cancer outcomes. Participants will not receive the usual adjuvant whole breast radiation therapy following breast conserving surgery. Instead, they will be followed over time to monitor their health status. The study is designed as a single arm cohort, meaning all enrolled women who meet the criteria will be observed without receiving radiation therapy. The first analysis is planned after a median follow-up of 5 years. Throughout the study, participants will undergo regular assessments to check for local, regional, and distant recurrence of breast cancer, as well as disease-free survival and overall survival. Any additional breast cancer treatments received after recurrence, such as repeat surgery, systemic therapy, or radiation, will be documented. The total participation duration is planned to extend up to 5 years, with ongoing monitoring to measure outcomes and safety.

Researchers are investigating the best treatment approaches for infections in artificial hip and knee joints. This study compares different surgical methods, antibiotic choices, and durations of antibiotic treatment to determine which combinations lead to the best outcomes and cure rates at 12 months. The trial focuses on adults with infected artificial joints and aims to address the significant health and economic impacts of prosthetic joint infections. Participants may receive one of several surgical strategies cleaning the infected joint without removing the implant DAIR, or revision surgery where the infected implant is replaced either in a single operation or two stages. Antibiotic treatments are also compared, with some participants receiving standard antibiotics alone and others receiving additional rifampicin. The study further explores different lengths of antibiotic courses after revision surgery, including shorter and longer durations and extended prophylaxis after two-stage revisions. During the study, participants consent to have their medical and treatment information collected in a central database and registry. Researchers will assess health status, infection cure, joint function, quality of life, and antibiotic use at 100 days and 12 months after starting the study. Outcomes like reinfection, survival, and revision surgeries will be monitored up to two years. This study does not require extra tests or treatments beyond routine care and follows participants closely to evaluate treatment success and safety.