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

NCT05404321 | Recruiting

• 1 other identifier: 2021-A02676-35
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Organoid; Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of establishment of exploitable organoids tumor

  4 years

Study Arms (1)

Patient with early stage triple negative breast cancer

Other: Establishment of ex vivo breast cancer organoid models

Interventions

Establishment of ex vivo breast cancer organoid models OTHER

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

Patient with early stage triple negative breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• Persons deprived of liberty or under guardianship (including curatorship)

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre François Baclesse

Caen, 14076, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37726786 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

George EMILE, MD

CONTACT

+33 2 31 45 50 50; g.emile@baclesse.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: January 9, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)