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)

Centre Francois Baclesse

Status: Enrolling

Conditions: Organoid; Triple Negative Breast Cancer

Treatments: Other: Establishment of ex vivo breast cancer organoid models

Study type: Observational

Funder types: Other

Identifiers

NCT05404321

2021-A02676-35

Details and patient eligibility

About

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.

Enrollment: 163 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

163 participants in 1 patient group

Patient with early stage triple negative breast cancer

Treatment:

Other: Establishment of ex vivo breast cancer organoid models