NCT04133077 Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer
| NCT ID | NCT04133077 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Jean Perrin |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2021-11-19 |
| Primary Completion | 2030-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2021-11-19 with a primary completion date of 2030-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Xavier DURANDO, Professor
PRINCIPAL INVESTIGATOR
Centre Jean Perrin
Frequently Asked Questions
Who can join the NCT04133077 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04133077 currently recruiting?
Yes, NCT04133077 is actively recruiting participants. Contact the research team at judith.passildas@clermont.unicancer.fr for enrollment information.
Where is the NCT04133077 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT04133077 clinical trial?
NCT04133077 is sponsored by Centre Jean Perrin. The principal investigator is Xavier DURANDO, Professor at Centre Jean Perrin. The trial plans to enroll 85 participants.
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