Strovolos

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Researchers are collecting detailed biological samples, imaging, environmental data, and patient-reported outcomes from cancer patients to support research aimed at understanding tumor biology and improving cancer care. This observational platform supports multiple projects focusing on different tumor types including thorax, head and neck, breast, gastrointestinal, genitourinary, central nervous system, and rare cancers. The goal is to enhance translational research, biomarker discovery, and clinical cancer study access. Participants provide tumor samples and clinical data which are analyzed using various genetic and molecular profiling techniques such as whole exome sequencing, RNA sequencing, and next-generation sequencing panels. Separate projects include studying young adults with rare cancers, molecular characterization of rare tumors, investigating molecular profiles in relation to environmental radon exposure, and assessing circulating tumor DNA as a marker for cancer recurrence. Participants are involved by providing biological material and clinical information, with data collected on tumor biology and treatment effects over five years. The study measures include understanding tumor biology, disease progression, treatment impact, biomarker identification, and matching patients to biomarker-driven clinical trials. Compliance with follow-up and consent are essential, and the study is designed to improve cancer patient care and research over an extended period.

Researchers are evaluating whether adding chemotherapy before surgery can improve outcomes for patients with high-risk dedifferentiated liposarcoma DDLPS and leiomyosarcoma LMS in the retroperitoneal area. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to improve disease-free survival for these patients. The study is randomized and open-label, involving multiple centers. Participants are randomly assigned to one of two groups. The standard group undergoes large curative surgery within four weeks after randomization. The experimental group receives three cycles of chemotherapy tailored to their sarcoma typedoxorubicin and ifosfamide for high-grade liposarcoma, or doxorubicin and dacarbazine for leiomyosarcomastarting within two weeks of randomization, followed by a reassessment and surgery within three to six weeks after the last chemotherapy cycle. During the study, patients are closely monitored through imaging and pathology reviews to confirm tumor characteristics and treatment effects. Researchers measure disease-free survival over seven years, along with overall survival, recurrence rates, response to chemotherapy, side effects, complications, and quality of life for up to eight years. Participants provide tumor tissue and blood samples for research, and their health and safety are carefully tracked throughout the study period.