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NCT Number: NCT04133077

Xenografts Development From Surgical Tumor Samples 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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean PERRIN

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

Location status: Recruiting

Location contact

Judith PASSILDAS JAHANMOHAN, PhD

CONTACT

[email protected]

0473270805

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples collection

Biological

Serology and genetic analyses will be performed in patients blood samples

Primary outcomes

  1. Percentage of successfull PDX

    Time frame: 2 years

    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.

Secondary outcomes

  1. Histological subtype

    Time frame: 2 years and 4 months

    Comparaison of initial tumor histological subtype with PDX histological subtype

  2. expression of estrogen receptors

    Time frame: 2 years and 4 months

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

  3. expression of progesterone receptors

    Time frame: 2 years and 4 months

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

  4. status of the amplification of the ERBB2 gene

    Time frame: 2 years and 4 months

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

  5. expression of androgen receptors

    Time frame: 2 years and 4 months

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

  6. tumor molecular classification

    Time frame: 2 years and 4 months

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

  7. Exome sequencing

    Time frame: 2 years and 4 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Judith PASSILDAS, PhD

CONTACT

[email protected]

+33463663337

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Acronym: XenoBreast

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Oct 21, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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