Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients

NCT ID: NCT04836156

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2026-12-31

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.

Conditions

HER2-negative Early Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant therapy base on PTC drug screening for triple negative early breast cancer

Patients with triple negative subtype will receive neoadjuvant chemotherapy based on PTC drug screening.

Group Type: EXPERIMENTAL

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer

Intervention Type: DRUG

The choice of chemotherapy is based on the PTC drug sensitivity results.

Neoadjuvant therapy base on PTC drug screening for luminal like early breast cancer

Patients with luminal like subtype will receive neoadjuvant chemotherapy based on PTC drug screening.

Group Type: EXPERIMENTAL

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer

Intervention Type: DRUG

The choice of chemotherapy is based on the PTC drug sensitivity results.

Interventions

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer

The choice of chemotherapy is based on the PTC drug sensitivity results.

Intervention Type: DRUG

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer

The choice of chemotherapy is based on the PTC drug sensitivity results.

Intervention Type: DRUG

Other Intervention Names

docetaxel and carboplatin; docetaxel and epirubicin; docetaxel and cyclophosphamide; epirubicin and cyclophosphamide; docetaxel and epirubicin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chaobin Wang, doctor

Role: CONTACT

hzwcb1990@163.com

+86-10-8832-4010

Facility Contacts

Chaobin Wang, doctor

Role: primary

hzwcb1990@163.com

+86-10-88324010

Other Identifiers

PekingUPH10B004

Identifier Type: -

Identifier Source: org_study_id