Cachoeiro De Itapemirim

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 treatments for adults with early-stage (stage II to IIIB) non-small cell lung cancer who are scheduled for surgery. The study aims to compare an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug against cemiplimab plus chemotherapy alone. The trial also explores side effects of these treatments, effects on the type of surgery performed, drug levels in the blood, and whether the body produces antibodies that might affect the treatment's effectiveness or cause side effects. Participants receive treatments through intravenous infusions. One group receives cemiplimab plus chemotherapy, while the other group receives cemiplimab, chemotherapy, and an additional drug called REGN7075. The treatments are given before surgery with the goal of shrinking tumors. The study is a randomized Phase 2 platform trial designed to assess these combined therapies in a perioperative setting. During the study, participants undergo evaluations including pathology reviews up to 12 weeks after treatment to determine tumor response. Researchers monitor major pathological responses and collect tumor samples. Safety and side effects are closely followed. Overall, the study involves treatment, surgery, and follow-up assessments to understand how well the treatments work and their safety profiles.

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 the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the use of adjuvant chemotherapy in patients with locally advanced cervical cancer who test positive for cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) in their plasma after standard treatment. This Phase 3, randomized, multicenter clinical trial aims to determine if patients with persistent cfHPV-DNA expression after chemoradiotherapy can benefit from additional chemotherapy. The study includes patients with cervical cancer stages IB3 to IVA who have completed standard concomitant chemoradiotherapy.

Researchers are evaluating treatments for advanced breast cancer characterized by estrogen receptor-positive, HER2-negative, and ESR1-mutated tumors. This study focuses on patients whose cancer has progressed despite previous endocrine therapy and CDK4/6 inhibitor treatment. The goal is to determine the effectiveness of combining elacestrant, a selective estrogen receptor degrader, with everolimus, a kinase inhibitor, compared to elacestrant with a placebo. This phase 3 trial aims to assess how well these treatments prolong the time patients live without disease progression or unacceptable side effects. A total of 240 patients will be randomly assigned to one of two groups: one receiving 345 mg of elacestrant plus 7.5 mg of everolimus daily, and the other receiving 345 mg of elacestrant plus a placebo daily. Treatment cycles last 28 days and continue until disease progression, unacceptable toxicity, death, or other reasons for stopping. Patients will be grouped based on the presence of visceral metastases and prior duration of CDK4/6 inhibitor therapy. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are tracked every three months for up to 12 months after the last patient is enrolled. Participants will undergo regular assessments including imaging scans to monitor cancer status and safety evaluations. The main measure is progression-free survival, defined as the time from treatment start until tumor progression, death, or discontinuation for other reasons, monitored on average for 12 months. Safety and treatment effectiveness will be closely followed throughout the study, with additional tumor assessments for those who stop treatment for reasons other than progression until new cancer therapy begins, death, or disease progression occurs.

Researchers are conducting a Phase III randomized clinical trial to evaluate the order of giving anthracyclines and taxanes as neoadjuvant chemotherapy for locally advanced HER2-negative breast cancer. The study includes 494 female patients with invasive breast carcinoma, focusing on whether starting treatment with anthracyclines or taxanes affects outcomes. Patients with triple-negative breast cancer may also receive carboplatin as part of their treatment. Participants will be randomized into two groups receiving the same chemotherapy drugs but in different sequences. One group will start with doxorubicin and cyclophosphamide given intravenously every 21 days for 3 cycles, while the other will start with either docetaxel given every 21 days for 4 cycles or weekly paclitaxel for 12 weeks. Other treatments such as surgery, radiotherapy, and hormone therapy will be given according to standard care and are not part of this study. During the study, participants will be closely monitored for invasive disease-free survival over an average of 8 years. Before starting treatment, patients will undergo assessments including cardiac function tests and evaluations of overall health and organ function. Researchers will collect data on treatment effects, safety, and survival outcomes to better understand the best sequence of chemotherapy drugs for this breast cancer type.

Researchers are evaluating treatment options for adults with metastatic colorectal cancer that has a specific KRAS p.G12C mutation. The study compares progression-free survival in patients who have not received prior treatment. The trial is a Phase 3, multicenter, randomized, open-label study focusing on this particular mutation to improve outcomes in this patient group. Participants will receive one of two treatment combinations. One group will receive sotorasib (an oral drug), panitumumab (given via intravenous infusion every two weeks), and the FOLFIRI regimen—a combination of irinotecan, leucovorin, and 5-fluorouracil administered intravenously every two weeks. The other group will receive FOLFIRI with or without bevacizumab-awwb, which is also given intravenously every two weeks. Treatments continue according to the study schedule to assess effectiveness. Throughout the study, participants will be monitored for progression-free survival using standard criteria (RECIST v1.1) for up to about three years. Researchers will assess tumor response and disease progression to evaluate treatment effects. Participants will undergo regular evaluations to monitor organ function and overall health status during the study period.