Guided chemotherapy for HER2-negative early breast cancer using drug screening
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
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04836156 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with stage IV breast cancer, inflammatory breast cancer, or severe chronic diseases may not benefit from this study.
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 performed: Preliminary studies using similar in vitro drug sensitivity screening methods have shown promising results, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.