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Clinical Trials in China / NCT04750122
Recruiting Phase 1/2

Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients

NCT04750122 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Phase 1/2
Started
2021-03-28
Last updated
2021-04-01

Condition(s) studied

HER2-positive Early Breast Cancer

Investigational drug(s) / intervention(s)

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning: 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 her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. 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 metheod for omitting chemotherapy for her2 positive participants.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * invasive breast cancer * HER2 positive * T2 or node positive * 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 Beijing Municipality Recruiting

More Peking University People's Hospital trials in China

Other trials for the same condition

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 NCT04750122 on ClinicalTrials.gov ↗ ← All trials in China