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

Triple Negative Breast Cancer Clinical Trial

— TRIPLEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404321
• Other study ID #: 2021-A02676-35
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: George EMILE, MD
• Phone: +33 2 31 45 50 50
• Email: g.emile[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 163
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Organoid
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of establishment of exploitable organoids tumor		4 years