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

NCT04133077 | Recruiting

• 1 other identifier: 2020-A00398-31
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

PDX

Outcome Measures

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.

  2 years

Secondary Outcomes (7)

• Histological subtype

  2 years and 4 months

• expression of estrogen receptors

  2 years and 4 months

• expression of progesterone receptors

  2 years and 4 months

• status of the amplification of the ERBB2 gene

  2 years and 4 months

• expression of androgen receptors

  2 years and 4 months

Study Arms (1)

Succeed PDX

OTHER

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

Biological: blood samples collection

Interventions

blood samples collection BIOLOGICAL

Serology and genetic analyses will be performed in patients blood samples

Succeed PDX

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean PERRIN

Clermont-Ferrand, Puy-de-Dôme, 63011, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34249349 DERIVED

Study Officials

• Xavier DURANDO, Professor

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith PASSILDAS, PhD

CONTACT

+33463663337; judith.passildas@clermont.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: November 19, 2021
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)