In short
There are currently 2 ongoing clinical trials investigating new treatments for inflammatory carcinoma of the breast. These trials are taking place across multiple European countries and are testing combinations of immunotherapy and chemotherapy approaches to help patients with this aggressive form of breast cancer.
Clinical trial locations
- Belgium
- France
- Italy
- Spain
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial is testing a new medication called DS-3939a in patients with advanced cancers that have spread beyond their original location. The medication is given directly into the bloodstream through an intravenous infusion.
Who can participate: Patients need to have a confirmed diagnosis of advanced cancer that cannot be removed by surgery, including breast cancer among other types. Participants must have a heart function measurement of at least 50% and adequate organ function. They should be able to carry out daily activities with minimal limitations, scoring 0 or 1 on a performance scale. The cancer must be measurable using standard imaging criteria. For the second part of the study, patients must show disease progression on scans during or after their most recent cancer treatment and be able to provide a tumor sample.
Who cannot participate: Patients who fall outside the specified age range for the study, those who belong to vulnerable populations such as pregnant women or those unable to give consent, and patients who do not meet safety requirements for the study drug are excluded.
What the trial is testing: The study is divided into two parts. The first part evaluates the safety and tolerability of DS-3939a, looking at how the body handles the drug and whether it causes harmful effects. The second part continues safety assessments while also measuring how effective the treatment is at shrinking or controlling tumors. Throughout the study, participants will be closely monitored with regular check-ups, laboratory tests, and imaging studies to track treatment progress.
Investigational drug: DS-3939a is an experimental cancer therapy designed to target specific pathways that cancer cells use to grow and spread. The exact mechanism is still under investigation, but the trial aims to determine if it is safe and effective for treating advanced solid tumors.
Study of Pembrolizumab and Cyclophosphamide for Patients with Inflammatory Breast Cancer on the Chest Wall
This trial is specifically focused on a rare and aggressive form of breast cancer that has spread to the chest wall. It combines two treatments: pembrolizumab, which helps the immune system fight cancer, and cyclophosphamide, a chemotherapy drug used in low doses over an extended period.
Who can participate: Patients must have breast cancer that has spread to the chest wall and cannot be removed by surgery, confirmed by biopsy showing certain markers like PDL1 or tumor infiltrating lymphocytes. They should have already received treatments such as chemotherapy or radiation therapy. Participants need to be fully active or have some symptoms but still capable of light work. Female patients of childbearing age must use birth control during the study and for 120 days after the last dose, and must have a negative pregnancy test before starting. Male patients must also agree to use birth control. Patients must have normal organ function based on laboratory tests, be expected to live for more than 3 months, be at least 18 years old, and provide tissue samples for testing.
Who cannot participate: Patients who have had a recent heart attack or severe heart problems, active infections requiring antibiotics, are pregnant or breastfeeding, have another uncontrolled type of cancer, have had an organ transplant, have a known allergy to the study drugs, are currently in another clinical trial, have severe liver or kidney disease, have a history of autoimmune diseases where the immune system attacks the body, or have received certain vaccines within a specific timeframe before the study are excluded.
What the trial is testing: The study will assess how effective pembrolizumab and cyclophosphamide are when used together in controlling cancer and improving quality of life. The treatment period lasts up to 24 months. Researchers will examine outcomes such as how long patients live without the cancer getting worse and how long the response to treatment lasts. Regular follow-up visits will monitor treatment response and side effects, with periodic imaging tests to assess the disease's response.
Investigational drugs: Pembrolizumab is an immunotherapy given as an intravenous infusion that blocks a specific protein on cancer cells, allowing the immune system to better recognize and attack them. Metronomic cyclophosphamide is taken orally as a tablet in a low-dose, continuous manner to minimize side effects while targeting cancer cells by interfering with their DNA and preventing them from growing and dividing.
Summary
Two clinical trials are currently available for patients with inflammatory carcinoma of the breast across Europe. One trial is taking place in Belgium, France, and Spain, testing the experimental drug DS-3939a for patients with various types of advanced cancers including breast cancer. The second trial is located in Italy and focuses specifically on inflammatory breast cancer that has spread to the chest wall, combining the established treatments pembrolizumab and cyclophosphamide.
Both trials represent different therapeutic approaches: one exploring a novel experimental agent and the other investigating a combination of immunotherapy and chemotherapy. The Italian trial is particularly relevant as it specifically targets the aggressive form of inflammatory breast cancer with chest wall involvement, while the multi-country trial offers an option for patients with advanced disease as part of a broader study of solid tumors.
