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

NCT04750122 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-04-01

No results posted yet for this 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.

Conditions

  • HER2-positive Early Breast Cancer

Interventions

DRUG

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning

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

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Shu Wang, doctor · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-28
Primary Completion
2022-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750122 on ClinicalTrials.gov