Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836156
Status:
RECRUITING
Last Update Posted:
2022-04-06
First Post:
2021-03-28
Brief Title:
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 HER2 Negative Early Breast Cancer Patients
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for Human Epidermal Growth Factor Receptor 2 HER2 Negative Early Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neoadjuvant treatment is an important treatment for early breast cancer patients Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs However not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects It was unknown for a patient who could benefit from which drug before chemotherapy Drug sensitivity screening in vitro was a promising method for choosing chemotherapy But there was no method could select effective drugs accurately for breast cancer patients until now
Previously investigators developed a patient-derived tumor-like cell clusters in vitro culture technology Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding And the results have been published This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants
Previously investigators developed a patient-derived tumor-like cell clusters in vitro culture technology Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding And the results have been published This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants
Detailed Description:
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs However not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects It was unknown for a patient who could benefit from which drug before chemotherapy Drug sensitivity screening in vitro was a promising method for choosing chemotherapy But there was no method could select effective drugs accurately for breast cancer participants until now
Previously investigators developed a patient-derived tumor-like cell clusters PTC in vitro culture technology It is a cell cluster including tumor cells mesenchymal cells and lymphocytes which simulates the tumor microenvironment in vitro In the preliminary exploration investigators included 35 early breast cancer participants the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well The results have been published
This study will focus on her2 negative early breast cancer participants 46 participants will be included All of them will received in vitro drug sensitivity screening upon PTC before neoadjuvant therapy The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results If single-agent chemotherapy is effective in vitro this drug will be the chemotherapy regimen for the corresponding participants
Previously investigators developed a patient-derived tumor-like cell clusters PTC in vitro culture technology It is a cell cluster including tumor cells mesenchymal cells and lymphocytes which simulates the tumor microenvironment in vitro In the preliminary exploration investigators included 35 early breast cancer participants the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well The results have been published
This study will focus on her2 negative early breast cancer participants 46 participants will be included All of them will received in vitro drug sensitivity screening upon PTC before neoadjuvant therapy The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results If single-agent chemotherapy is effective in vitro this drug will be the chemotherapy regimen for the corresponding participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None