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
| NCT ID | NCT05404321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Francois Baclesse |
| Condition | Triple Negative Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 163 participants |
| Start Date | 2023-01-09 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 163 participants in total. It began in 2023-01-09 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05404321 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05404321 currently recruiting?
Yes, NCT05404321 is actively recruiting participants. Contact the research team at g.emile@baclesse.unicancer.fr for enrollment information.
Where is the NCT05404321 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05404321 clinical trial?
NCT05404321 is sponsored by Centre Francois Baclesse. The trial plans to enroll 163 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.