Skip to content

Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer

A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04133077
Acronym
XenoBreast
Enrollment
85
Registered
2019-10-21
Start date
2021-11-19
Completion date
2030-08-31
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Keywords

PDX

Brief summary

Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. However, the realization of such PDX (from primitive mammary tumors or after neoadjuvant treatment) would make it possible to have a better knowledge of the tumor heterogeneity to the therapeutic response, to explore the models of tumor evolution during metastatic progression and also observe the mechanisms of tumor resistance in the case of non-metastatic tumors. It therefore seems necessary to develop PDX from primitive tumors in order to observe firstly the success rate of PDX; on the other hand, the drift of the initial heterogeneity, measured by comparison of the histomolecular profile of the tumors with that of the PDXs. It aims to develop xenografts from tumor samples from surgical specimens of patients with triple negative or luminal B breast cancer.

Interventions

Serology and genetic analyses will be performed in patients blood samples

Sponsors

Centre Jean Perrin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

The intervention consists in the realization of additional blood samples to carry out serologies and genetic analyses

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2 * Signature of the participation consent to the study, * Affiliation to a social security scheme * Major woman with: * metastatic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of neoadjuvant treatment * metaplastic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, treated by primary surgery with a tumor size of at least 15 mm on the specimen. * an inflammatory TN breast cancer (T4d), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment. * non-metaplastic or inflammatory TN breast cancer, histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment. * Luminal B breast cancer (LB), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment. * histologically proven metastatic TN or metastatic breast cancer with an operable metastasis whose residual size, after chemotherapy, is at least 10 mm on the specimen. Residual metastasis will be at least 15 mm on imaging. * Patients in a metastatic situation can be included regardless of the therapeutic line.

Exclusion criteria

* Pregnant woman * Patient deprived of liberty by court or administrative decision * In neoadjuvant situation: no neoadjuvant treatment by radiotherapy or hormone therapy * Refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Percentage of successfull PDX2 yearsPDX will be realized from patient tumor by transplanting a small fragment in a nude mouse. Once the tumor is enough grown up, the tumor is extracted to repeat this step 3 times until we get the fourth PDX with a successful tumor growth.

Secondary

MeasureTime frameDescription
Histological subtype2 years and 4 monthsComparaison of initial tumor histological subtype with PDX histological subtype
expression of estrogen receptors2 years and 4 monthsComparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors
expression of progesterone receptors2 years and 4 monthsComparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors
expression of androgen receptors2 years and 4 monthsComparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors
tumor molecular classification2 years and 4 monthsComparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)
status of the amplification of the ERBB2 gene2 years and 4 monthsComparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status
Exome sequencing2 years and 4 monthsComparaison of genetic alterations between intial tumor, PDX and blood sample

Countries

France

Contacts

CONTACTJudith PASSILDAS, PhD
judith.passildas@clermont.unicancer.fr+33463663337
PRINCIPAL_INVESTIGATORXavier DURANDO, Professor

Centre Jean Perrin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026