October marks Breast Cancer Awareness Month, a time to honor the strength of patients, survivors, and the continued efforts of those advancing cancer research. At GCT, we celebrate this month not only in words but through our work — by contributing to innovative breast cancer clinical trials that bring new hope for patients.
After skin cancer, breast cancer remains the most common cancer diagnosed among women in the United States — though it can occur in both women and men. At GCT, we are proud to have successfully managed a Phase I clinical trial in patients with breast cancer across 4 active sites.
The study aimed to evaluate the safety, tolerability, and pharmacokinetics of a novel Investigational Medicinal Product (IMP) using a dose-escalation method in patients with palindromic or refractory metastatic breast cancer and was sponsored by a biotechnology start-up specializing in oncology research.
All study activities have now been completed, and the Clinical Study Report (CSR) has been submitted to the Regulatory Authorities and Local Ethics Committees (LECs). The Trial Master File (TMF) has also been sent for archiving.
Following the success of the Phase I study, GCT is now supporting the Sponsor with the preparation of a scientific publication based on the study’s results, while also providing medical writing services for the upcoming Phase II study, which has already been approved by the Regulatory Authority.
This promising new therapy is the first drug developed from a modified oncogenic virus. Preclinical studies demonstrated its ability to effectively eliminate cancer cells, and scientists believe it may also target metastases — a major step forward in cancer treatment.
GCT provided full-service project management, including regulatory support, clinical site monitoring and management, and drug logistics.
“It was a great excitement for us as a team to work on a breakthrough therapy aimed at fighting the most common type of cancer” –
said Dr. Eugene Selivra, GCT CEO,
“GCT is proud to have achieved significant milestones on this important project in a short period of time. We supported it in full compliance with international quality standards and are thrilled to expand our oncology trials portfolio while building a strong partnership with our satisfied client”.
At GCT, we take pride in advancing cancer research and improving outcomes for patients worldwide. Breast cancer survival rates continue to rise, and mortality is steadily declining — thanks to earlier detection, personalized treatments, and a deeper understanding of the disease.
GCT is an experienced partner in conducting oncology clinical trials, including breast cancer studies.
StoContact us at bd@gctrials.com to learn more or discuss your next project.