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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Jean PERRIN
RECRUITING
Clermont-ferrand
Contact Information
Primary
Judith PASSILDAS, PhD
judith.passildas@clermont.unicancer.fr
+33463663337
Time Frame
Start Date: 2021-11-19
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 85
Treatments
Other: Succeed PDX
Genetic analysis will be performed in patients who got a successful PDX
Related Therapeutic Areas
Sponsors
Leads: Centre Jean Perrin

This content was sourced from clinicaltrials.gov

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