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

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples collection
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer Female focused on measuring PDX

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Jean PERRINRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Succeed PDX

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2019
Last Updated
March 9, 2022
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT04133077
Brief Title
Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer
Acronym
XenoBreast
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
PDX

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The intervention consists in the realization of additional blood samples to carry out serologies and genetic analyses
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Succeed PDX
Arm Type
Other
Arm Description
Genetic analysis will be performed in patients who got a successful PDX
Intervention Type
Biological
Intervention Name(s)
blood samples collection
Intervention Description
Serology and genetic analyses will be performed in patients blood samples
Primary Outcome Measure Information:
Title
Percentage of successfull PDX
Description
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 Outcome Measure Information:
Title
Histological subtype
Description
Comparaison of initial tumor histological subtype with PDX histological subtype
Time Frame
2 years and 4 months
Title
expression of estrogen receptors
Description
Comparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors
Time Frame
2 years and 4 months
Title
expression of progesterone receptors
Description
Comparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors
Time Frame
2 years and 4 months
Title
status of the amplification of the ERBB2 gene
Description
Comparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status
Time Frame
2 years and 4 months
Title
expression of androgen receptors
Description
Comparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors
Time Frame
2 years and 4 months
Title
tumor molecular classification
Description
Comparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)
Time Frame
2 years and 4 months
Title
Exome sequencing
Description
Comparaison of genetic alterations between intial tumor, PDX and blood sample
Time Frame
2 years and 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith PASSILDAS, PhD
Phone
+33463663337
Email
judith.passildas@clermont.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, Professor
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean PERRIN
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith PASSILDAS JAHANMOHAN, PhD
Phone
0473270805
Email
judith.passildas@clermont.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34249349
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.
Results Reference
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Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer

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