Peking University People's Hospital
Beijing, China
Location status: Recruiting
Recruiting
NCT Number: NCT04836156
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- invasive breast cancer
- HER2 negative
- T2 or node positive
- Eastern Cooperative Oncology Group(ECOG) 0-1
Exclusion criteria
- stage IV
- inflammatory breast cancer
- Severe chronic disease
Treatment and study plan
neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer
DrugThe choice of chemotherapy is based on the PTC drug sensitivity results.
Other names: docetaxel and carboplatin, docetaxel and epirubicin
neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer
DrugThe choice of chemotherapy is based on the PTC drug sensitivity results.
Other names: docetaxel and cyclophosphamide, epirubicin and cyclophosphamide, docetaxel and epirubicin
Primary outcomes
-
pathological complete response(pCR)
Time frame: up to 24 weeks
ypT0/is, ypN0
Secondary outcomes
-
event-free survival (EFS)
Time frame: 5 years
The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause
-
invasive disease-free survival (IDFS)
Time frame: 5 years
The time from surgery to the first documented occurrence of an event defined as ipsilateral invasive local recurrence, ipsilateral locoregional invasive recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause
-
objective response rate
Time frame: up to 24 weeks
complete response and partial response
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking University People's Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2026
- First posted
- Apr 8, 2021
- Registry last updated
- Apr 6, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.