Breast neoplasm Trials in Disease

Study on the Effects of Selumetinib, Bicalutamide, and Olaparib in Patients with Metastatic Breast Cancer

This clinical trial is investigating a new approach to treating metastatic breast cancer, which is breast cancer that has spread to other parts of the body such as bones, liver, lungs, or brain. The study is testing a combination of three oral medications: Selumetinib, Bicalutamide (brand name Casodex), and Olaparib. These medications work in different ways to target cancer cells and stop their growth.

Main inclusion criteria:

• Patients must be female and at least 18 years old
• Must have confirmed breast cancer that has spread to other parts of the body and cannot be removed by surgery
• The cancer must have specific molecular changes that can be identified through testing
• Patients must be able to swallow oral medications and have normal heart function, with a left ventricular ejection fraction greater than 50%
• Must have tumors that can be measured using imaging tests, or have a recent tumor sample available
• Expected to live for at least 3 more months
• Must be able to perform light work or be fully active, though some disease symptoms are acceptable
• The disease must be showing signs of progression
• For HER2-positive breast cancer, patients must have already received at least two previous treatments targeting HER2
• Women of childbearing potential must have a negative pregnancy test within 14 days before starting the study

Main exclusion criteria:

• Patients without metastatic breast cancer cannot participate
• Male patients are not eligible for this trial
• Patients considered part of vulnerable populations who may need special protection in research

Focus and goal of the trial:

The main goal of this study is to determine whether this combination of targeted medications can help patients live longer without their cancer getting worse, compared to standard chemotherapy. The trial uses an approach called SHARP, which involves advanced genetic sequencing technology to analyze the tumor's genetic makeup and help doctors make more personalized treatment decisions. This precision medicine approach aims to match the right treatment to each patient based on their cancer's specific characteristics.

Participants will be randomly assigned to receive either the experimental treatment combination or standard chemotherapy. The study will last up to 12 months, during which patients will take the medications orally and attend regular check-ups. Throughout the trial, patients will undergo various assessments including imaging tests like MRI to monitor how the cancer responds to treatment.

Investigational drugs:

The trial is testing three medications taken by mouth:

• Selumetinib: A kinase inhibitor that blocks specific proteins involved in cancer cell growth
• Bicalutamide (Casodex): An antiandrogen medication that blocks male hormone activity
• Olaparib: A PARP inhibitor that prevents cancer cells from repairing their DNA damage

The study uses the SHARP Oncochip system, which is a next-generation sequencing-based tool designed to help guide treatment decisions by analyzing the genetic information of the cancer. This allows for a more personalized approach to cancer treatment.

Summary

Currently, there is one active clinical trial for breast neoplasm, specifically focused on metastatic breast cancer. The trial is being conducted in Italy and represents an innovative approach to cancer treatment through precision medicine. By using genetic sequencing to understand the specific characteristics of each patient's cancer, the study aims to determine whether a combination of three targeted oral medications can provide better outcomes than standard chemotherapy.

The trial is designed for female patients whose breast cancer has spread to other parts of the body and focuses on measuring how long patients can live without disease progression. The study uses medications that target different pathways in cancer cells, potentially offering a more effective treatment approach. The estimated completion date for this trial is December 2025.

Patients interested in participating should discuss with their healthcare provider whether they meet the eligibility criteria, particularly regarding the molecular characteristics of their cancer and their overall health status.