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NCT Number: 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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre François Baclesse

Caen, 14076, France

Location status: Recruiting

Location contact

Adeline MOREL, MD

SUB_INVESTIGATOR

Alison JOHNSON, MD

SUB_INVESTIGATOR

Audrey FAVEYRIAL, MD

SUB_INVESTIGATOR

Carine SEGURA, MD

SUB_INVESTIGATOR

Christelle LEVY, MD

SUB_INVESTIGATOR

Djelila ALLOUACHE, MD

SUB_INVESTIGATOR

George EMILE, MD

CONTACT

[email protected]

+33 2 31 45 50 50

George EMILE, MD

PRINCIPAL_INVESTIGATOR

Ioana HRAB, MD

SUB_INVESTIGATOR

Julien GEFFRELOT, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Establishment of ex vivo breast cancer organoid models

Other

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

Primary outcomes

  1. Rate of establishment of exploitable organoids tumor

    Time frame: 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

George EMILE, MD

CONTACT

[email protected]

+33 2 31 45 50 50

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: TRIPLEX

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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