NCT05404321Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 163 (estimated)
- First submitted
- 31 May 2022
- Start date
- 9 Jan 2023
- Primary completion date
- Jun 2028
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05404321
What you commit to
- Study type: Observational
- Planned participants: 163
- From 9 Jan 2023 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of any other clinically active malignancy in the last 5 years prior to inclusion
Other
- Pregnant women
- Persons deprived of liberty or under guardianship (including curatorship)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.