San Salvador De Jujuy

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 conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating the effectiveness and safety of Zanidatamab combined with Cisplatin and Gemcitabine, with or without an added PD-1/L1 inhibitor (either Durvalumab or Pembrolizumab), as a first treatment for people with advanced HER2-positive biliary tract cancer. This study focuses on participants whose tumors show specific HER2 markers and aims to compare this combination to standard care. It is a Phase 3 trial involving patients with locally advanced or metastatic disease who have received limited prior treatment. Participants receive Zanidatamab, Cisplatin, and Gemcitabine all through intravenous (IV) infusions. Some may also receive a PD-1/L1 inhibitor chosen by their doctor, depending on local approvals. Treatments are given as part of the first-line therapy for advanced disease. The study includes screening to confirm HER2-positive status using biopsy tissue and standard imaging to assess the cancer. The study does not include a separate extension phase but follows participants during treatment and observation. During the trial, participants are monitored for progression-free survival for up to 52 months. Researchers will assess tumor response using standard criteria and regularly check participants' health, organ function, and side effects. Women of childbearing potential must have negative pregnancy tests and use birth control, and all participants must have a good performance status. Safety assessments, including laboratory tests and monitoring for adverse events, are ongoing throughout the study to ensure participant well-being.

Gallstones are common in women and are a major risk factor for gallbladder cancer (GBC), a serious disease with limited treatment options. This research aims to improve how well we can predict the risk of GBC and detect it early by studying differences in geography, environment, lifestyle, ethnicity, gender, and molecular markers. The goal is to develop better prevention programs and improve understanding of how lifestyle and genetic factors contribute to GBC development. The study involves collecting epidemiological, clinical, and dietary information, along with samples of blood, saliva, urine, bile, feces, and gallbladder tissue. These samples will be used to identify and study new biomarkers for GBC, build a biorepository, develop a risk scoring system, and explore new treatment options. The study includes patients with gallbladder cancer or precancerous conditions and those with gallstones scheduled for gallbladder removal. Participants will provide various samples and data which researchers will use to measure the number of participants developing gallbladder cancer or dysplasia, either at the start or after examination of removed gallbladders. The project also supports training researchers and aims to help shape health policies. The study is observational and does not involve any experimental treatments, focusing instead on gathering data to improve prevention, diagnosis, and future treatments for GBC.

Researchers are evaluating the safety and effectiveness of palazestrant (OP-1250) compared to standard treatments fulvestrant or an aromatase inhibitor in adults with ER-positive, HER2-negative advanced or metastatic breast cancer. Participants have previously received endocrine therapy combined with a CDK4/6 inhibitor, and their cancer has progressed despite this treatment. This phase 3, international, randomized, open-label trial aims to provide new information on treatment options for this population. Participants will be assigned to receive either palazestrant daily in a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or standard endocrine therapy with fulvestrant or one of three aromatase inhibitors (anastrozole, letrozole, or exemestane), given according to their approved schedules. After selecting the optimal palazestrant dose, more participants will be randomized to receive either that dose or standard care. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for adverse events, dose reductions, or treatment discontinuation for up to 16 weeks after randomization. The main outcome is progression-free survival, measured until disease progression or death, with an estimated follow-up of up to 2 years. Assessments will include physical exams, lab tests, and regular evaluations of cancer status and side effects to ensure safety and track the effectiveness of the treatments.

Researchers are evaluating a new combination treatment of Sigvotatug Vedotin plus pembrolizumab compared to pembrolizumab alone in adults with non-small cell lung cancer (NSCLC) that has high levels of PD-L1 protein. This study focuses on participants with advanced or metastatic NSCLC (Stage 3 or 4) who have PD-L1 expression in at least 50% of their tumor cells. The purpose is to understand how well the combination works versus pembrolizumab alone as a first treatment option. All participants receive pembrolizumab through an intravenous infusion once every 6 weeks at the study clinic. Half of the participants will also receive Sigvotatug Vedotin as an intravenous infusion every 2 weeks along with pembrolizumab. Participants may continue pembrolizumab treatment for up to about two years, while those receiving Sigvotatug Vedotin can continue until their cancer no longer responds to the treatment. During the study, participants will have regular clinic visits where researchers monitor their health and response to treatment. The main outcomes measured include overall survival up to approximately two years and progression-free survival, which tracks the time until cancer worsens or death. Safety and side effects will be closely observed throughout the study period to understand the treatments' impact.