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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Biological: blood samples collection

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judith PASSILDAS, PhD; Phone Number: +33463663337; Email: judith.passildas@clermont.unicancer.fr

Study Locations

• France
  • Puy-de-Dôme
    • Clermont-Ferrand, Puy-de-Dôme, France, 63011
      • Recruiting
      • Centre Jean Perrin
      • Contact: Judith PASSILDAS JAHANMOHAN, PhD; Phone Number: 0473270805; Email: judith.passildas@clermont.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Succeed PDX; Genetic analysis will be performed in patients who got a successful PDX	Biological: blood samples collection; Serology and genetic analyses will be performed in patients blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological subtype	Comparaison of initial tumor histological subtype with PDX histological subtype	2 years and 4 months
expression of estrogen receptors	Comparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors	2 years and 4 months
expression of progesterone receptors	Comparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors	2 years and 4 months
status of the amplification of the ERBB2 gene	Comparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status	2 years and 4 months
expression of androgen receptors	Comparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors	2 years and 4 months
tumor molecular classification	Comparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)	2 years and 4 months
Exome sequencing	Comparaison of genetic alterations between intial tumor, PDX and blood sample	2 years and 4 months

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Xavier DURANDO, Professor, Centre Jean Perrin

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PDX
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-A00398-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No