RecruitingPhase 1Phase 2NCT04836156

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

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


Sponsor

Peking University People's Hospital

Enrollment

46 participants

Start Date

Apr 2, 2021

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether personalized chemotherapy — chosen based on how a patient's cancer cells respond to drugs in the lab — works better than standard chemotherapy for people with early-stage HER2-negative breast cancer before surgery. **You may be eligible if:** - You have invasive breast cancer - Your cancer tests negative for HER2 (a specific protein) - Your tumor is larger (T2) or has spread to nearby lymph nodes - You are in generally good health and able to carry out daily activities (ECOG score 0–1) **You may NOT be eligible if:** - Your cancer has spread to other parts of the body (stage IV) - You have inflammatory breast cancer - You have severe ongoing health problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGneoadjuvant 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.

DRUGneoadjuvant 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.


Locations(1)

Peking University People's Hospital

Beijing, China

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NCT04836156