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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.
Actively Recruiting
Researchers are evaluating treatments for adults with early-stage stage II-IIIB non-small cell lung cancer who are scheduled for surgery. The study compares an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug, REGN7075, against cemiplimab plus chemotherapy without the additional drug. The study also investigates side effects, effects on surgery type, drug levels in blood, and the bodys antibody response to the drugs. Participants are randomly assigned to one of two study groups one group receives cemiplimab plus chemotherapy, and the other group receives cemiplimab plus chemotherapy plus REGN7075. All drugs are given by intravenous infusion. The study focuses on the period leading up to surgery and includes up to 12 weeks for assessing major pathologic response and other tumor-related outcomes. During the study, participants will undergo medical evaluations including tumor measurements using pathology review, blood tests to monitor drug levels and antibodies, and assessments of side effects. Researchers will track event-free and overall survival outcomes for up to 5 years and monitor adverse events for up to 76 weeks. The total study duration may extend to several years for long-term monitoring of treatment effects and safety.
Actively Recruiting
Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.
Actively Recruiting
Researchers are examining the use of extreme hypofractionation radiotherapy in selected Brazilian patients with breast cancer. This study aims to evaluate cancer control outcomes and side effects related to this treatment approach using data collected retrospectively. It focuses on patients treated with this specific radiotherapy method in clinical practice since December 2019. Data will be collected from medical records of up to 500 women diagnosed with any subtype of breast cancer who received five sessions of 5.2 Gy radiotherapy after surgery. There is no intervention in this study patients continue their usual care as determined by their medical teams. The study gathers clinical, demographic, socioeconomic, treatment, and outcome information from participating centers across Brazil. Participants medical records will be reviewed to assess locoregional cancer recurrence over an 18-month period. Since this is observational, no changes to treatment are made, and patients maintain regular evaluations and care. The study collects detailed clinical data without altering standard treatment or requiring additional procedures, with data collection ongoing until June 2025.