Guided chemotherapy for HER2-negative early breast cancer using drug screening
Official title: 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
Run by Peking University People's Hospital · NCT04836156 · Data updated 2026-11-12
This study is testing a new way to choose the best chemotherapy drugs for people with early HER2-negative breast cancer by using lab tests on their tumor cells before treatment starts.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 46 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | April 2, 2021 |
| Main results expected | June 30, 2022 |
| Study ends | December 31, 2026 |
| Registry record updated | April 6, 2022 |
| Trial ID | NCT04836156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with invasive HER2-negative early breast cancer who are either T2 or node positive and have an ECOG performance status of 0-1.
✕Probably not a fit
Patients with stage IV breast cancer, inflammatory breast cancer, or severe chronic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of in vitro drug sensitivity screening to guide neoadjuvant chemotherapy for patients with HER2-negative early breast cancer. By utilizing a novel patient-derived tumor-like cell cluster technology, the study aims to identify which chemotherapy drugs are most effective for individual patients before treatment begins. A total of 46 participants will undergo this screening to tailor their chemotherapy regimen, potentially improving treatment outcomes and reducing unnecessary side effects. The study builds on preliminary findings that suggest a strong correlation between in vitro drug sensitivity and clinical outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective chemotherapy treatments for patients with HER2-negative early breast cancer.
How similar studies have gone: Preliminary studies using similar in vitro drug sensitivity screening methods have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Peking University People's Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Shu Wang, doctor — Peking University People's Hospital
- Study coordinator: Chaobin Wang, doctor
- Email: hzwcb1990@163.com
- Phone: +86-10-8832-4010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.