Establishment of an ex Vivo Tumor Collection of Triple-ne... | NCT05404321

Studies
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

NCT05404321

Sponsor

Centre Francois Baclesse

Status

Recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

163Estimated

Phase

Not provided

Conditions

Triple Negative Breast Cancer
Organoid

Interventions

Establishment of ex vivo breast cancer organoid models

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2023Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

May 31, 2022

First Submission Date that Met QC Criteria

May 31, 2022

First Posted Date

Jun 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

163Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with early stage triple negative breast cancer			Other: Establishment of ex vivo breast cancer organoid models

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of establishment of exploitable organoids tumor		4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
George EMILE, MD	Contact	+33 2 31 45 50 50		g.emile@baclesse.unicancer.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre François Baclesse	Recruiting	Caen		14076	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37726786	Derived	Divoux J, Florent R, Jacobs M, Lequesne J, Grellard JM, San C, Grossi S, Kerdja K, Clarisse B, Boudier G, Cherifi F, Briand M, Dolivet E, Johnson A, Dubois B, Harter V, Lacroix J, Raboutet C, Marie B, Rousseau N, Blanc-Fournier C, Vaur D, Figeac M, Poulain L, Weiswald LB, Emile G. The TRIPLEX study: use of patient-derived tumor organoids as an innovative tool for precision medicine in triple-negative breast cancer. BMC Cancer. 2023 Sep 19;23(1):883. doi: 10.1186/s12885-023-11362-8.

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases