Üçlü Negatif veya Luminal B Meme Kanseri Olan Hastaların Cerrahi Tümör Örneklerinden Ksenograft Geliştirilmesi

Sade dilde özet

Bu çalışma, üçlü negatif (triple negative) veya Luminal B meme kanseri (breast cancer) olan hastaların ameliyatla alınan tümör örneklerinden laboratuvar modelleri (ksenograft) geliştirmeyi ve bu amaçla kan örnekleri toplamayı amaçlamaktadır. Çalışmaya, histolojik olarak doğrulanmış üçlü negatif veya Luminal B meme kanseri olan yetişkin kadın hastalar alınmaktadır. Çalışma faz uygulanmayan bir çalışma olarak yürütülmektedir ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Katılımcı alıyor

Sponsor

Centre Jean Perrin

Müdahale

blood samples collection

Başlangıç

19.11.2021

Tahmini bitiş

31.08.2030

Ülkeler

France

İlgili genler

Merkezler

• Clermont-Ferrand, France

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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