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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Jean Perrin

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

Signature of the participation consent to the study,

Affiliation to a social security scheme

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • blood samples collection

    Biological/Vaccine

    Serology and genetic analyses will be performed in patients blood samples

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Succeed PDXOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.