Clinical trial NCT05404321: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Triple Negative Breast Cancer
Organoid
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 163
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of establishment of exploitable organoids tumor
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References: