Cachoeiro De Itapemirim

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

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.

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 evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are investigating whether patients with locally advanced cervical cancer who still have detectable cell-free human papillomavirus DNA cfHPV-DNA in their plasma after standard treatment may benefit from additional chemotherapy. This trial is a prospective, randomized, multicenter clinical study designed to evaluate adjuvant chemotherapy based on this biomarker. The study focuses on patients who have undergone chemoradiotherapy and have persistent cfHPV-DNA, as this may indicate ongoing disease activity. Participants first receive standard treatment with concomitant chemoradiotherapy, including doses of radiation and weekly cisplatin. Four weeks after completing this treatment, a blood test is conducted to detect cfHPV-DNA in plasma. Patients with positive cfHPV-DNA results are randomly assigned to either receive two additional cycles of adjuvant chemotherapy with cisplatin and gemcitabine or to be monitored without further chemotherapy. Patients in both groups undergo regular follow-up every four months, including plasma cfHPV-DNA testing, CT scans of the chest, MRI scans of the abdomen and pelvis, and clinical and gynecological exams. During the study, participants are closely monitored for progression-free survival, overall survival, treatment response, quality of life, and any toxic effects of treatment. Follow-up assessments occur at regular intervals from 7 to 120 days after treatment. The total duration of participant involvement varies based on follow-up schedules. The study uses a single-blind design and randomized allocation to ensure scientific rigor while maintaining patient safety throughout the trial period.

Researchers are evaluating a treatment for advanced breast cancer that is estrogen receptor-positive, HER2-negative, and has a specific ESR1 gene mutation. The study aims to find out how well a combination of elacestrant, a selective estrogen receptor degrader, and everolimus, a kinase inhibitor, works in patients whose cancer has progressed despite prior endocrine therapy and CDK46 inhibitor treatment. The study follows strict guidelines to ensure patient safety and compliance with international clinical standards. Participants will be randomly assigned to one of two groups. One group will receive elacestrant at 345 mg plus everolimus at 7.5 mg orally once daily, while the other group will receive elacestrant at the same dose plus a placebo instead of everolimus. Treatments will be given in 28-day cycles and continue until disease progression, unacceptable side effects, or other reasons for stopping the treatment occur. After stopping treatment, patients will be followed every three months for up to one year to monitor survival and any new cancer therapies. During the study, patients will undergo scans such as CT or MRI to confirm disease status, and tests to assess tumor markers and gene mutations. Researchers will monitor treatment effects, safety, and quality of life using questionnaires like the EQ-5D-5L and EORTC QLQ-C30 and QLQ-BR42. Side effects, blood counts, liver and kidney function, heart activity, and overall health status will be regularly checked. The main outcome is progression-free survival, measuring how long patients live without cancer worsening during treatment, with other outcomes including overall survival and treatment response. The total study duration for each participant averages about 12 months.

Researchers are evaluating the best sequence of chemotherapy drugs for treating locally advanced HER2-negative breast cancer. This phase III, open-label, randomized trial includes 494 female patients with invasive breast carcinoma stages IIB to III. The study compares starting treatment with either anthracyclines plus cyclophosphamide or taxanes, with or without carboplatin for triple-negative subtypes, to determine which sequence is more effective. Participants are randomly assigned to one of two treatment groups. One group receives doxorubicin and cyclophosphamide intravenously every 21 days for three cycles, followed by docetaxel every 21 days for four cycles or weekly paclitaxel for 12 weeks. The other group starts with docetaxel or paclitaxel followed by doxorubicin and cyclophosphamide on the same schedule. Other treatments like surgery, radiotherapy, and hormone therapy are given according to usual care and are not part of the study. Throughout the study, participants undergo regular assessments including cardiac function tests such as echocardiogram or MUGA before treatment starts. The main outcome measured is invasive disease-free survival over an average of eight years. The trial monitors patient health and treatment response but does not alter standard post-chemotherapy care. Participation involves signing informed consent and agreeing to use contraception during and after treatment as required.

Researchers are studying advanced breast cancer patients who have mutations in BRCA1, BRCA2, or PALB2 genes and whose cancer is hormone receptor-positive and HER2-negative. The study aims to compare the effectiveness of saruparib AZD5305 combined with camizestrant against standard treatments involving CDK46 inhibitors plus endocrine therapy. This is a phase III clinical trial conducted to evaluate treatment options for this specific breast cancer group. Participants will be randomly assigned to one of four treatment groups saruparib plus camizestrant physicians choice of CDK46 inhibitor plus endocrine therapy physicians choice of CDK46 inhibitor plus camizestrant or saruparib plus physicians choice endocrine therapy. Treatments are given orally or by injection according to the group, and continue until the disease progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo assessments to monitor disease progression and treatment effects, including scans and laboratory tests. Researchers will measure progression-free survival and other outcomes such as overall survival, response rates, and quality of life over several years. Safety and tolerability will also be closely observed throughout the study period, which may last up to about 88 months.

This research aims to compare progression-free survival in adults with metastatic colorectal cancer harboring the KRAS p.G12C mutation who have not yet received treatment. The study evaluates the effectiveness of combining sotorasib, panitumumab, and FOLFIRI chemotherapy versus FOLFIRI chemotherapy with or without bevacizumab-awwb. This comparison is important for understanding treatment options for this specific cancer mutation. Participants will be randomly assigned to one of two treatment groups. One group will take sotorasib orally every day along with panitumumab and FOLFIRI given by intravenous infusion every two weeks. The other group will receive FOLFIRI chemotherapy every two weeks, with or without bevacizumab-awwb infusion. Treatments will continue as per study protocol to assess their impact on cancer progression. During the study, participants will have their disease monitored using imaging tests based on RECIST v1.1 criteria for up to about three years to measure progression-free survival. Additional outcomes such as overall survival, response rates, duration of response, and adverse events will be tracked for up to five years. The study includes regular medical assessments, laboratory tests, and safety monitoring throughout the treatment and follow-up periods.