Invasive ductal breast carcinoma Trials in Disease

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This clinical trial is testing a new treatment called DS-3939a for patients with advanced or metastatic solid tumors, including invasive ductal breast carcinoma that has spread beyond its original location. The medication is given directly into the bloodstream through a vein, a method called intravenous infusion. The study is taking place in France, Spain, and Belgium and is divided into two parts: the first part focuses on evaluating the safety of DS-3939a, while the second part looks at both safety and how effective the treatment is at controlling or shrinking tumors.

Main inclusion criteria:

• Patients must sign an informed consent form agreeing to participate in the study
• Heart function must be adequate, with a left ventricular ejection fraction of at least 50%
• All major organs must be functioning properly
• The cancer must be measurable according to standard criteria called RECIST V1.1
• Patients must have an Eastern Cooperative Oncology Group performance status score of 0 or 1, meaning they are either fully active or have some symptoms but can still carry out light activities
• For Part 1: Patients must have locally advanced, metastatic, or unresectable cancer in the bladder, lung, breast, ovary, bile duct, or pancreas
• For Part 2: Patients must have cancer that has progressed during or after their most recent treatment
• For Part 2: Patients must be able to provide a tumor sample, either fresh or from a previous biopsy done within 6 months

Main exclusion criteria:

• Patients who do not meet the specified age range for the study
• Patients who belong to vulnerable populations, such as pregnant women or those unable to provide consent
• Patients who do not meet the safety and tolerability requirements for DS-3939a

Focus and goal of the trial:

The main purpose of this study is to evaluate how safe DS-3939a is and whether patients can tolerate it well. The trial also aims to measure how effective the treatment is by looking at something called the objective response rate, which tells researchers what percentage of patients experience tumor shrinkage or disappearance after treatment. Throughout the study, participants will be closely monitored with regular check-ups, laboratory tests, heart function tests, and imaging studies to track their progress and watch for any side effects. The study is expected to be completed by July 2027.

Investigational drug:

DS-3939a is an experimental medication designed to treat advanced solid tumors. It works by targeting specific pathways that cancer cells use to grow and spread, although the exact mechanism is still being studied. The drug is administered as an injection in a clinical setting by healthcare professionals. It is not yet approved for general medical use and is being tested to determine if it is safe and effective for treating cancers like invasive ductal breast carcinoma that have advanced or spread to other parts of the body.

Summary

Currently, there is one clinical trial available for patients with invasive ductal breast carcinoma as part of a broader study examining advanced solid tumors. This trial is being conducted across three European countries: Belgium, France, and Spain, providing access to patients in multiple locations. The study focuses on testing DS-3939a, an experimental drug that targets specific cancer cell pathways. The trial offers an opportunity for patients whose cancer has advanced or spread to participate in research that may lead to new treatment options. Patients interested in participating should discuss eligibility criteria with their healthcare provider, as the study has specific requirements regarding heart function, organ health, and previous treatments.