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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Francois Baclesse

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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 population

Patient with early stage (I-III) triple negative breast cancer who needs to have clips placed before neoadjuvant chemotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Establishment of ex vivo breast cancer organoid models

    Other intervention

    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

Treatment groups

163 Participants
are divided into 1 treatment group
Group A: Patient with early stage triple negative breast cancer1 intervention

Trial outcomes

Primary outcomes

1

Rate of establishment of exploitable organoids tumor

Time frame
4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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