Invasive breast carcinoma Trials in Disease

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

This trial is testing a new medication called DS-3939a for people with advanced or metastatic solid tumors, including breast cancer. The study is being conducted in Belgium, France, and Spain.

Who can participate: Participants must be adults with locally advanced, metastatic, or unresectable cancer. For Part 1 of the study, patients with cancer in the bladder, lung, breast, ovary, bile duct, or pancreas may be eligible. For Part 2, patients must have experienced disease progression during or after their most recent treatment. All participants must have a heart function test showing at least 50% ejection fraction, adequate organ function, and measurable disease according to standard criteria. They must also have a performance status score of 0 or 1, meaning they are either fully active or able to carry out light work. A tumor sample is required for Part 2 participants.

Who cannot participate: Patients outside the specified age range or those who do not meet safety requirements for DS-3939a cannot join. Vulnerable populations, including pregnant women and those unable to provide informed consent, are excluded.

What the trial involves: The study is divided into two parts. The first part focuses on evaluating the safety and tolerability of DS-3939a, while the second part measures how effective the treatment is at shrinking or controlling tumors. DS-3939a is given as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. Throughout the trial, participants will undergo regular monitoring including laboratory tests, heart function checks, vital signs assessments, and imaging studies to track treatment progress and any side effects.

Investigational drug: DS-3939a is an experimental medication that targets specific pathways used by cancer cells to grow and spread. The trial aims to determine if it is safe and effective for treating advanced solid tumors.

Study on Indocyanine Green for Evaluating Surgical Margins in Patients Undergoing Breast-Conserving Surgery for Early Invasive Breast Cancer

This trial is studying whether a special imaging technique using indocyanine green can help surgeons better identify cancer margins during breast-conserving surgery. The study is taking place in Belgium.

Who can participate: This trial is open to women aged 18 and older who have been diagnosed with early-stage ductal invasive breast cancer. Eligible participants must have primary early-stage disease classified as cT1 or cT2, based on tumor size and extent. They must be planning to undergo breast-conserving surgery and should not have had previous breast cancer surgery on the affected breast. Participants must have a performance status score of 0 or 1, indicating they are fully active or nearly fully active despite some symptoms.

Who cannot participate: The trial excludes patients who do not have primary invasive early breast cancer or who are not planning breast-conserving surgery. Men, patients outside the specified age range, and vulnerable populations not eligible for the study are also excluded.

What the trial involves: Before surgery, participants will receive an injection of indocyanine green into a vein. This special dye lights up under certain light conditions, allowing surgeons to see the edges of the cancer more clearly during the operation. The study will test different doses and timing of the injection to determine the most effective approach. The goal is to help surgeons remove all cancerous tissue while preserving as much healthy breast tissue as possible, potentially reducing the need for additional surgery.

Investigational approach: Indocyanine green is a fluorescent dye used in medical imaging. In this trial, it helps visualize tumor margins during surgery by binding to proteins in the blood and fluorescing under near-infrared light.

Summary

These two clinical trials represent different approaches to addressing invasive breast carcinoma. The first trial focuses on advanced or metastatic disease, testing a new systemic treatment across three European countries. The second trial addresses early-stage disease with a surgical innovation available in Belgium. Together, these studies reflect ongoing efforts to improve outcomes for patients at different stages of breast cancer, from enhancing surgical precision in early disease to exploring new treatment options for advanced cases.