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

Breast Cancer Female Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04133077
• Other study ID #: 2020-A00398-31
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: Centre Jean Perrin
• Contact: Judith PASSILDAS, PhD
• Phone: +33463663337
• Email: judith.passildas[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Biological:
• blood samples collection
Serology and genetic analyses will be performed in patients blood samples

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont-Ferrand	Puy-de-Dôme

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Histological subtype	Comparaison of initial tumor histological subtype with PDX histological subtype	2 years and 4 months
Secondary	expression of estrogen receptors	Comparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors	2 years and 4 months
Secondary	expression of progesterone receptors	Comparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors	2 years and 4 months
Secondary	status of the amplification of the ERBB2 gene	Comparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status	2 years and 4 months
Secondary	expression of androgen receptors	Comparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors	2 years and 4 months
Secondary	tumor molecular classification	Comparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)	2 years and 4 months
Secondary	Exome sequencing	Comparaison of genetic alterations between intial tumor, PDX and blood sample	2 years and 4 months