Ongoing Clinical Trials for Hormone Receptor Negative HER2 Positive Breast Cancer
Currently, there is 1 ongoing clinical trial investigating treatment approaches for hormone receptor negative HER2 positive breast cancer. This trial is being conducted in France and focuses on using advanced imaging techniques to guide treatment decisions for patients with metastatic breast cancer who have experienced cancer recurrence after initial hormone therapy.
Clinical trial locations
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 clinical trial investigates how a specialized imaging technique can improve treatment decisions for patients with metastatic breast cancer. The study focuses on patients whose cancer is estrogen receptor-positive (ER+) and HER2-negative, meaning their cancer cells respond to the hormone estrogen but do not have excess HER2 protein. Participants are those who have experienced cancer recurrence after completing their first line of treatment with hormone therapy.
Main inclusion criteria:
- Women aged 18 years or older
- Diagnosed with primary breast cancer showing high levels of estrogen receptors (ER ≥ 10%)
- HER2-negative breast cancer
- Metastatic stage disease with cancer spread to other body parts, with at least one identifiable area of cancer outside the liver
- Cancer recurrence after first-line treatment that included a CDK4/6 inhibitor and hormone therapy
- Previous or planned FDG PET/CT scan showing cancer relapse, with 2 to 28 days between scans
- ECOG performance status of 0, 1, or 2 (able to carry out self-care activities)
- Life expectancy of at least 12 months
Main exclusion criteria:
- Patients without metastatic breast cancer showing estrogen receptor overexpression and HER2 negativity
- Those who have not experienced relapse after first-line hormone therapy
- Male patients
- Patients outside the specified age range
- Individuals considered part of vulnerable populations not eligible for this study
Focus and goals:
The trial aims to understand how Fluoroestradiol F-18 (FES) PET imaging can help doctors make better-informed treatment decisions. Patients undergo PET scans using FES, which allows doctors to visualize estrogen receptor activity in cancer cells throughout the body. This information guides treatment planning, which may involve adjusting hormone therapy, adding or withdrawing medications, or modifying chemotherapy approaches.
The study follows a structured timeline beginning with initial assessment and baseline PET/CT scanning, followed by treatment planning based on scan results. A follow-up scan occurs within 2 to 28 days to monitor treatment response. The trial continues with ongoing monitoring to assess progression-free survival and treatment effectiveness, with formal evaluation at 3 months.
Investigational drug:
The study uses FLUOROESTRADIOL F-18 (FES), also known as EstroTep. This is a radiopharmaceutical imaging agent injected into the body and used in PET scans. FES attaches to estrogen receptors in cancer cells, allowing doctors to see how much estrogen activity is present in tumors. This visualization helps guide decisions about whether to continue, modify, or change hormone-based treatments. FES is not a treatment itself but rather a diagnostic tool to improve treatment selection.
Summary
Currently, there is one active clinical trial for patients with hormone receptor negative HER2 positive breast cancer, located in France. This trial represents an innovative approach using advanced imaging technology to personalize treatment decisions for patients with metastatic disease who have experienced cancer recurrence after initial hormone therapy. The focus on Fluoroestradiol F-18 PET imaging reflects growing interest in precision medicine approaches that can help doctors select the most appropriate treatments based on individual cancer characteristics. Patients interested in this trial should discuss eligibility with their healthcare providers.
