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RecruitingNCT04133077XenoBreastUpdated Mar 19, 2026

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

An interventional study of blood samples collection in Breast Cancer Female, sponsored by Centre Jean Perrin. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer Female

Keywords

  • PDX
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • Other
    Succeed PDX

    Genetic analysis will be performed in patients who got a successful PDX

    Biological: blood samples collection

Interventions

  • Biologicalblood samples collection

    Serology and genetic analyses will be performed in patients blood samples

05

What researchers measure

Primary outcomes

  1. Percentage of successfull PDX

    PDX 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.

    Time frame: 2 years

Secondary outcomes

  1. Histological subtype

    Comparaison of initial tumor histological subtype with PDX histological subtype

    Time frame: 2 years and 4 months

  2. expression of estrogen receptors

    Comparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors

    Time frame: 2 years and 4 months

  3. expression of progesterone receptors

    Comparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors

    Time frame: 2 years and 4 months

  4. status of the amplification of the ERBB2 gene

    Comparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status

    Time frame: 2 years and 4 months

  5. expression of androgen receptors

    Comparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors

    Time frame: 2 years and 4 months

  6. tumor molecular classification

    Comparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)

    Time frame: 2 years and 4 months

  7. Exome sequencing

    Comparaison of genetic alterations between intial tumor, PDX and blood sample

    Time frame: 2 years and 4 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Veyssiere H, Passildas J, Ginzac A, Lusho S, Bidet Y, Molnar I, Bernadach M, Cavaille M, Radosevic-Robin N, Durando X. XENOBREAST Trial: A prospective study of xenografts establishment from surgical specimens of patients with triple negative or luminal b breast cancer. F1000Res. 2020 Oct 9;9:1219. doi: 10.12688/f1000research.26873.3. eCollection 2020. PubMed 34249349 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04133077
Lead sponsor
Centre Jean Perrin
Responsible party
Sponsor
First posted
Oct 21, 2019
Start date
Nov 19, 2021
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Mar 19, 2026

Study contacts

Judith PASSILDAS, PhD
Contact
judith.passildas@clermont.unicancer.fr
+33463663337
Xavier DURANDO, Professor
principal investigator · Centre Jean Perrin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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