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Clinical Trials in China / NCT04836156
Recruiting Phase 1/2

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

NCT04836156 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Phase 1/2
Started
2021-04-02
Last updated
2022-04-06

Condition(s) studied

HER2-negative Early Breast Cancer

Investigational drug(s) / intervention(s)

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

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing China Recruiting

More Peking University People's Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04836156 on ClinicalTrials.gov ↗ ← All trials in China