Breast angiosarcoma Trials in Disease

Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment

This clinical trial is designed for patients with soft tissue sarcoma, including angiosarcoma, whose cancer has spread to other parts of the body or who did not respond well to previous treatments. The study is being conducted in Germany and will continue until March 2029.

Main inclusion criteria:

• Patients must be between 18 and 75 years old
• Must have advanced or metastatic soft tissue sarcoma, including angiosarcoma, that did not respond to previous anthracycline treatment or cannot take anthracycline medications due to medical reasons
• The cancer must be high-grade (grade 2-3) and confirmed through laboratory testing
• The tumor must test positive for CD13, a specific protein marker, with a score of 1 or higher
• Must have at least one measurable tumor that has not been previously treated with radiation
• Life expectancy of at least 3 months
• Ability to carry out daily activities (ECOG Performance Status of 2 or less)
• Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 3 months after treatment ends
• Men must use birth control methods for 5 months after the last treatment

Main exclusion criteria:

• Age below 18 or above 75 years
• No confirmed diagnosis of soft tissue sarcoma
• No previous treatment with anthracycline medications
• Negative test result for CD13 protein marker
• Currently pregnant or breastfeeding
• Previous treatment with trabectedin
• Severe heart, liver, or kidney problems
• Active uncontrolled infections
• Other active cancers requiring treatment
• Known allergic reactions to the study medications
• Participation in another clinical trial within the past 30 days

Focus and goal of the trial:

The study compares two different treatment approaches for soft tissue sarcoma. Participants will be randomly assigned to one of two groups: one receiving trabectedin alone, and another receiving trabectedin combined with tTF-NGR. The main goal is to determine if adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time. The experimental drug tTF-NGR is designed to concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective.

During the study, participants will receive treatment through intravenous infusion directly into the bloodstream for up to 360 days. Regular medical examinations and imaging tests will be performed to monitor how the cancer responds to the treatment. After treatment completion, patients will continue to be monitored, with women required to use effective contraception for 3 months and men for 5 months following the last treatment.

Investigational drugs:

Trabectedin is a cancer medication used to treat soft tissue sarcoma. It works by interfering with cancer cell growth and division. This medication is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively.

tTF-NGR is an experimental therapy designed to work together with trabectedin. It is a protein that targets blood vessels in tumors and is intended to help trap the cancer medication inside the tumor. This combination approach aims to make the cancer treatment more effective by keeping the medication concentrated where it is needed most.

Summary

Currently, there is only one clinical trial available specifically for patients with breast angiosarcoma. This trial is being conducted in Germany and focuses on patients whose cancer has spread or did not respond to previous treatment. The study investigates whether adding an experimental drug called tTF-NGR to standard trabectedin chemotherapy can improve treatment outcomes compared to using trabectedin alone. The trial requires participants to have tumors that test positive for CD13, a specific protein marker, and excludes patients who have already been treated with trabectedin. The study represents an important opportunity for patients with advanced soft tissue sarcomas, including angiosarcoma, who have limited treatment options after first-line therapy has failed.