One year after the opening of the TRIPLEX trial, 37 patients with triple-negative breast cancer are already included in this research protocol with organoids...
A look back at the study and triple-negative breast cancer
In January 2023, medical teams and researchers at the Centre Baclesse launched a new organoid clinical trial involving patients with triple-negative breast cancer. This type of breast cancer accounts for around 15% of the 61,000 breast cancers diagnosed in France each year(source INCa 2023), and is characterized by the absence of hormone receptors and the absence of overexpression of the HER2 receptor (a protein naturally present in the body). Highly aggressive, it mainly affects young women and carries a higher risk of recurrence.
The development of new methods for predicting response to treatment is a major challenge in triple-negative breast cancer today. Indeed, despite a good response to initial treatment, the rate of metastatic recurrence remains very high, with approximately 20-30% of relapses. Cancer can recur within the breast itself, in the form of local recurrence, or at a distance, in other organs or tissues, in the form of metastases.
Subtypes of breast cancer
Aim of the study
The aim of the TRIPLEX study is "to test different treatments on patient tumors reproduced in the laboratory, in order to determine which treatment will be the most effective", explained Dr. George EMILE, medical oncologist and head of the UCP Sein at the Centre Baclesse, when the study was launched.
The study is divided into two stages:
- Step 1: Build up a collection of tumor and blood samples. These are processed by the ORGAPRED platform and the Tumorothèque de Caen Basse-Normandie, which also manages their storage.
- Step 2: Analyze the "ex vivo" response (tests performed outside the body in a laboratory) of tumor samples to treatment, to develop functional tests and identify biomarkers predictive of response to treatment.
The ORGAPRED platform is dedicated to the production of tumor organoids (also known as tumoroids) for predictive and research purposes. It is a platform of the University of Caen Normandie hosted by the François Baclesse Cancer Center within the Inserm Unit U1086 ANTICIPE. The scientific managers are : Laurent POULAIN and Louis-Bastien WEISWALD (Researchers).
ORGAPRED Laboratory
TRIPLEX study diagram
An update from Dr George Emile
- Several objectives have been pursued since the study began. Can you give us some initial details?
"The main objective was to determine whether we could develop an organoid solely from a biopsy, and we had estimated our success rate at 30%. To date, 37 patients have been included in the trial, and we have obtained organoids in 80% of cases, which is excellent news. However, the length of time they can be maintained in culture is only a few weeks, and we are finding it difficult to keep them proliferating. We are therefore currently working on miniaturization processes to enable us to assess the response to treatment as soon as the tumoroids appear. It's a real challenge to work with so little biological material. Indeed, the sample taken during a biopsy represents a very small fragment of tissue (the size of a needle), hence the challenge represented by the method used in this clinical protocol."
- What about your secondary objective, which was to determine whether the organoids developed correlated well with the original tumors?
"Characterization of the organoids is underway, but remains difficult on so little material. The team is continuing to fine-tune techniques for both culture and organoid characterization. This is a priority objective for 2024."
- What's next for the TRIPLEX trial?
"Treat the organoids with the chemotherapies and immunotherapies administered to the patients. This crucial stage of the clinical trial will begin shortly, as the team finalizes the last manipulations to standardize the process. The team will then be able to concentrate on the resistant organoids and test new treatments or new therapeutic strategies (new treatment combinations) for subsequent administration to patients. Ultimately, the hope is to develop personalized medicine for each patient, avoiding treatments that we know will be ineffective. Tomorrow's oncology is moving towards precision medicine, which requires, in addition to the availability of effective alternative treatments, the identification of biomarkers enabling the selection of patients likely to benefit from these new therapeutic strategies".
Inclusion of patients in the clinical trial will extend over 4 years, and will involve a total of 163 patients.
