Clinical trial NCT04133077: Xenografts Development from Surgical Tumor Samples of Patients with Triple Negative or Luminal B Breast Cancer
Official title: A Prospective Study of Xenografts Development from Samples Taken from Surgical Specimens of Patients with Triple Negative or Luminal B Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: PDX
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention consists in the realization of additional blood samples to carry out serologies and genetic analyses
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of successfull PDX
timeFrame: 2 years
Secondary outcomes:
measure: Histological subtype
timeFrame: 2 years and 4 months
measure: expression of estrogen receptors
timeFrame: 2 years and 4 months
measure: expression of progesterone receptors
timeFrame: 2 years and 4 months
measure: status of the amplification of the ERBB2 gene
timeFrame: 2 years and 4 months
measure: expression of androgen receptors
timeFrame: 2 years and 4 months
measure: tumor molecular classification
timeFrame: 2 years and 4 months
measure: Exome sequencing
timeFrame: 2 years and 4 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
state: Puy-de-Dôme
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.