Oestrogen receptor gene overexpression Trials in Disease

Study on the Impact of Fluoroestradiol F-18 PET on Treatment for Patients with ER+ HER2- Metastatic Breast Cancer After First-Line Hormone Therapy Relapse

This trial is being conducted in France and focuses on patients with metastatic breast cancer that has specific characteristics. The cancer must be estrogen receptor-positive (ER+), meaning the cancer cells grow in response to the hormone estrogen, and HER2-negative, meaning the cancer cells do not have an excess of the HER2 protein.

Main inclusion criteria: The trial is open to women aged 18 years or older who have metastatic breast cancer with at least 10% estrogen receptor expression and confirmed HER2-negative status. Participants must have experienced a return of their cancer after completing first-line treatment that included both a CDK4/6 inhibitor and hormone therapy. They must have at least one identifiable area of cancer spread outside the liver and should have a life expectancy of at least 12 months. Additionally, patients need to have an ECOG performance status of 0, 1, or 2, which measures their ability to perform daily activities.

Main exclusion criteria: Patients who do not have metastatic breast cancer with estrogen receptor overexpression and HER2-negative status are not eligible. The trial also excludes those who have not experienced cancer relapse after first-line hormone therapy, male patients, and individuals outside the specified age range or considered part of vulnerable populations.

Focus and goal: The primary aim of this study is to understand how a special imaging technique called Fluoroestradiol F-18 PET can improve treatment decisions for patients whose cancer has returned. The trial involves performing PET scans using an imaging agent called 18F-fluoroestradiol (also known as FES or EstroTep), which attaches to estrogen receptors in the body and allows doctors to visualize how active these receptors are in cancer cells. Patients will undergo an initial PET/CT scan, followed by treatment planning based on the results, and then a follow-up scan within 2 to 28 days. The study will evaluate how this imaging information impacts treatment choices, which may include adjusting hormone therapy, adding or changing medications, or modifying chemotherapy approaches. The ultimate goal is to determine whether this imaging technique helps doctors make more informed treatment decisions and improves patient outcomes.

Investigational drug: The main agent being tested is 18F-fluoroestradiol (FES), a radiopharmaceutical imaging agent administered through injection. FES is designed to attach to estrogen receptors in cancer cells, making them visible during a PET scan. This helps doctors assess how much estrogen activity is present in the cancer, which is crucial for determining the most appropriate treatment strategy for patients with estrogen receptor-positive breast cancer.

Summary

Currently, there is one active clinical trial addressing oestrogen receptor gene overexpression in the context of metastatic breast cancer. This trial is taking place in France and represents an innovative approach to managing cancer that has returned after initial hormone therapy. The study focuses specifically on using advanced imaging technology to guide treatment decisions rather than testing a new cancer treatment drug directly. The trial is particularly relevant for patients with ER+ HER2- metastatic breast cancer who have exhausted their first-line treatment options and are seeking personalized approaches to their care. This research may help establish whether imaging with fluoroestradiol can become a valuable tool in tailoring treatment strategies for this specific patient population.