Developing tumor models from breast cancer samples
A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer
This study is trying to create new tumor models from breast cancer samples to help understand how different tumors behave and respond to treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Jean Perrin Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Clermont-Ferrand, Puy-de-Dôme) |
| Trial ID | NCT04133077 on ClinicalTrials.gov |
What this trial studies
This study focuses on creating patient-derived xenografts (PDX) from surgical tumor samples of patients with triple negative or luminal B breast cancer. By utilizing these samples, the research aims to enhance understanding of tumor heterogeneity, therapeutic responses, and mechanisms of tumor resistance. The study specifically targets primitive mammary tumors or those after neoadjuvant treatment, which are less commonly used in PDX development. The goal is to compare the histomolecular profiles of the original tumors with those of the developed PDXs to assess success rates and tumor evolution.
Who should consider this trial
Good fit: Ideal candidates include women with metastatic triple-negative or luminal B breast cancer who have a tumor size of at least 15 mm after neoadjuvant chemotherapy.
Not a fit: Patients with non-metastatic breast cancer or those who do not meet the specific tumor size criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for breast cancer by providing insights into tumor behavior and resistance mechanisms.
How similar studies have performed: While patient-derived xenografts have been explored in various contexts, this specific approach focusing on primitive tumors and post-neoadjuvant treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand, Puy-de-Dôme
- Centre Jean PERRIN — Clermont-Ferrand, Puy-de-Dôme, France (Recruiting)
Study contacts
- Principal investigator: Xavier DURANDO, Professor — Centre Jean Perrin
- Study coordinator: Judith PASSILDAS, PhD
- Email: judith.passildas@clermont.unicancer.fr
- Phone: +33463663337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.