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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05404321
Acronym
TRIPLEX
Enrollment
163
Registered
2022-06-03
Start date
2023-01-09
Completion date
2028-12-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organoid, Triple Negative Breast Cancer

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.

Interventions

OTHEREstablishment 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

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of establishment of exploitable organoids tumor4 years

Countries

France

Contacts

CONTACTGeorge EMILE, MD
g.emile@baclesse.unicancer.fr+33 2 31 45 50 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026