Breast angiosarcoma metastatic 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 being conducted in Germany and investigates treatment options 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.

Main focus and goal: The study compares two different treatment approaches to determine which is more effective at keeping the cancer under control. One group of participants receives trabectedin alone, while the other group receives a combination of trabectedin and tTF-NGR. The trial aims to find out if adding tTF-NGR to standard trabectedin treatment helps control the cancer for a longer period. The study will continue until March 2029 and involves treatment for up to 360 days, with regular medical examinations and imaging tests to monitor how the cancer responds.

Investigational drugs:

• Trabectedin is a cancer medication that works by interfering with cancer cell growth and division. It is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively. The medication is given through an intravenous infusion directly into the bloodstream.
• tTF-NGR is an experimental drug designed to work together with trabectedin. It 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.

Who can participate: The trial is open to adults between 18 and 75 years of age who have advanced or metastatic soft tissue sarcoma, including angiosarcoma. Participants must have previously received treatment with anthracycline medications that did not work, or they must have medical reasons that prevent them from taking anthracyclines. The cancer must be high-grade (grade 2-3) and must test positive for a specific protein marker called CD13 with a score of 1 or higher. Participants must have at least one measurable tumor that has not been previously treated with radiation and a life expectancy of at least 3 months. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 3 months after. Men must use birth control methods for 5 months after the last treatment.

Who cannot participate: The trial excludes individuals who are younger than 18 or older than 75 years. People who have not received previous anthracycline therapy or who test negative for the CD13 protein marker cannot join. Pregnant or breastfeeding women are not eligible. Those who have previously been treated with trabectedin, have severe heart, liver, or kidney problems, active uncontrolled infections, or other active cancers requiring treatment are excluded. Patients who have known allergic reactions to the study medications or who have participated in another clinical trial within the past 30 days also cannot take part.

What to expect during the trial: After initial evaluation and confirmation that you meet the study criteria, including testing for CD13 positivity, you will be randomly assigned to one of two treatment groups. You will receive your assigned treatment through intravenous infusion, and treatment will continue until your disease progresses or other stopping criteria are met. Throughout the study, regular imaging tests will track your tumor's response to treatment, and your overall health status will be monitored. If you are of childbearing potential, monthly pregnancy tests will be required. After treatment completion, follow-up monitoring will continue according to the study schedule.