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

Официальное название

A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Percentage of successfull PDX [Срок оценки: 2 years]

Вторичные конечные точки (7)

• Histological subtype [Срок оценки: 2 years and 4 months]
• expression of estrogen receptors [Срок оценки: 2 years and 4 months]
• expression of progesterone receptors [Срок оценки: 2 years and 4 months]
• status of the amplification of the ERBB2 gene [Срок оценки: 2 years and 4 months]
• expression of androgen receptors [Срок оценки: 2 years and 4 months]
• tumor molecular classification [Срок оценки: 2 years and 4 months]
• Exome sequencing [Срок оценки: 2 years and 4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Centre Jean PERRIN — Clermont-Ferrand

Публикации

• 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. PMID 34249349

Идентификаторы

NCT: NCT04133077 · 2020-A00398-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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