Concepcion

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating MK-5684, a study medicine that blocks the body from making steroid hormones, to treat certain solid tumors including breast, ovarian, and endometrial cancers. The goal is to find out if people receiving MK-5684 live longer without their cancer growing or spreading compared to those receiving standard treatments. This is a phase 2, open-label study involving participants with specific types of hormone receptor positive breast cancer, high-grade ovarian cancer, and low-grade endometrioid carcinoma. Participants will receive MK-5684 tablets orally as the investigational treatment. The study also includes standard care drugs such as fludrocortisone, dexamethasone, fulvestrant, exemestane, megestrol acetate, tamoxifen, and letrozole, delivered via tablets or injections as needed. The study is divided into cohorts based on cancer type and prior treatments, with participants receiving the appropriate therapies according to their cohort classification. During the study, participants will be monitored up to approximately two years for progression-free survival, which measures the length of time without cancer growth or spread. Researchers will assess participants' recovery from previous therapies, manage any side effects, and monitor HIV or hepatitis virus status if applicable. Various assessments including clinical evaluations and safety monitoring will be conducted throughout the participation period to evaluate treatment effects and participant health.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are investigating the effects of opevesostat compared to alternative treatments abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC). This phase 3, randomized, open-label study focuses on participants who have already been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to assess overall survival (OS) in participants with and without androgen receptor ligand binding domain (AR LBD) mutations, hypothesizing that opevesostat may improve survival. Participants will receive either oral opevesostat or an alternative hormonal agent such as abiraterone acetate or enzalutamide. Additional supportive medications like hydrocortisone, fludrocortisone acetate, prednisone, or dexamethasone may be given orally or as needed. The study compares these treatments directly during the trial period. Throughout the study, participants will provide tumor tissue samples and undergo regular assessments including imaging scans, laboratory tests, and performance status evaluations. Researchers will monitor overall survival for up to approximately 54 months, differentiating outcomes based on AR LBD mutation status. Safety and treatment effects will be carefully tracked during this time to evaluate the benefits and risks of the treatments.

Researchers are evaluating the safety and effectiveness of Volrustomig in women with high-risk locally advanced cervical cancer (stages IIIA to IVA) who have not experienced disease progression after completing platinum-based concurrent chemoradiation therapy (CCRT). This phase III, randomized, double-blind, placebo-controlled global study aims to provide new insights for this patient group by comparing Volrustomig to a placebo treatment. Participants will be randomly assigned in equal numbers to receive either Volrustomig or a placebo, both given through intravenous infusion. The study is conducted across multiple centers worldwide, maintaining a double-blind design to ensure unbiased results. Treatment details include administration of the investigational drug or placebo after completion of their initial CCRT. During the study, participants will be monitored for progression-free survival based on assessments by investigators, with follow-up lasting up to about seven years. Researchers will evaluate health status, organ function, and any side effects through regular clinical assessments and laboratory tests. Safety and long-term outcomes will be closely tracked to understand the impact of Volrustomig in this setting.