Clinical trial NCT04836156: Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: HER2-negative Early Breast Cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pathological complete response(pCR)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: event-free survival (EFS)
timeFrame: 5 years
measure: invasive disease-free survival (IDFS)
timeFrame: 5 years
measure: objective response rate
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Shu Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: