Establishment of an ex Vivo Tumor Collection of Triple-negative Breast Cancers in Order to Validate the Interest of Innovative Therapies and the Search for Predictive Biomarkers of Response to Treatment (TRIPLEX)

Initially described in 2009 on LGR5 positive stem cells from intestine, organoids correspond to a 3D cell culture that preserves the organization and part of the initial function of the organ from which the cells were derived. They use the proliferation and differentiation properties of stem cells cultured in a three-dimensional matrix.

These principles have been adapted to many human organs, including the breast. These culture conditions have thus allowed the establishment of cancer organoid lines that have the advantages of rapid amplification, a high rate of establishment success and unlimited proliferation potential. They are transfectable and cryopreservable. They are very close morphologically and genetically to the tumor from which they derive. Very recently, the in vivo response of orthotopic xenograft models of breast cancer organoids has been correlated to the in vitro response of these same organoids. In addition, the in vitro response of various of these models to PARP inhibitors was linked to the presence of the BRCA1/2 mutant signature, highlighting the potential of these models to predict patient response to these treatments.

Furthermore, one study demonstrated the value of using organoids derived from metastatic gastrointestinal tumors to predict patient response to cancer treatments (100% sensitivity, 93% specificity, 88% positive predictive value, and 100% negative predictive value.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer; Organoid
• Intervention / Treatment: Other: Establishment of ex vivo breast cancer organoid models

• Study Type: Observational
• Enrollment (Estimated): 163

Contacts and Locations

• Study Contact: Name: George EMILE, MD; Phone Number: +33 2 31 45 50 50; Email: g.emile@baclesse.unicancer.fr

Study Locations

• France
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
    • Sub-Investigator: Christelle LEVY, MD
    • Sub-Investigator: Adeline MOREL, MD
    • Sub-Investigator: Audrey FAVEYRIAL, MD
    • Sub-Investigator: Djelila ALLOUACHE, MD
    • Sub-Investigator: Julien GEFFRELOT, MD
    • Sub-Investigator: Carine SEGURA, MD
    • Sub-Investigator: Ioana HRAB, MD
    • Sub-Investigator: Alison JOHNSON, MD
    • Contact: George EMILE, MD; Phone Number: +33 2 31 45 50 50; Email: g.emile@baclesse.unicancer.fr
    • Principal Investigator: George EMILE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with early stage (I-III) triple negative breast cancer who needs to have clips placed before neoadjuvant chemotherapy

Description

Inclusion Criteria:

• Patient over 18 years of age
• Patient with early stage (I-III) triple negative breast cancer who needs to have clips placed before neoadjuvant chemotherapy
• Patient affiliated to a social security system
• Proficiency in French language,
• Patient having signed the consent to participate in the study.

Exclusion Criteria:

• Pregnant women
• Persons deprived of liberty or under guardianship (including curatorship)
• History of any other clinically active malignancy in the last 5 years prior to inclusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with early stage triple negative breast cancer	Other: Establishment of ex vivo breast cancer organoid models; This study includes 2 steps: The constitution of a collection of tumor and blood samples and the analysis of the ex vivo response of the tumor samples to the treatments for the development of functional tests and the research of predictive biomarkers of this response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of establishment of exploitable organoids tumor	4 years

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Publications and helpful links

General Publications

• Divoux J, Florent R, Jacobs M, Lequesne J, Grellard JM, San C, Grossi S, Kerdja K, Clarisse B, Boudier G, Cherifi F, Briand M, Dolivet E, Johnson A, Dubois B, Harter V, Lacroix J, Raboutet C, Marie B, Rousseau N, Blanc-Fournier C, Vaur D, Figeac M, Poulain L, Weiswald LB, Emile G. The TRIPLEX study: use of patient-derived tumor organoids as an innovative tool for precision medicine in triple-negative breast cancer. BMC Cancer. 2023 Sep 19;23(1):883. doi: 10.1186/s12885-023-11362-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 2021-A02676-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No