Neoadjuvant therapy guided by drug screening for HER2 positive early breast cancer
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for HER2 Positive Early Breast Cancer Patients
This study is testing if certain patients with early HER2-positive breast cancer can skip chemotherapy by using drug screening to find out which treatments work best for them.
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 | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04750122 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of neoadjuvant therapy for patients with HER2-positive early breast cancer, focusing on the potential to exempt certain patients from chemotherapy based on in vitro drug sensitivity screening. The approach utilizes patient-derived tumor-like cell clusters to simulate the tumor microenvironment and identify effective treatments. By determining which patients can safely avoid chemotherapy, the study aims to reduce adverse reactions while maintaining treatment efficacy. The research builds on previous findings that suggest a 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-positive 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 study could lead to more personalized treatment plans that minimize chemotherapy exposure for patients with HER2-positive early breast cancer.
How similar studies have performed: Previous studies have shown promising results using similar in vitro drug sensitivity screening methods, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * invasive breast cancer * HER2 positive * T2 or node positive * ECOG 0-1 Exclusion Criteria: * stage IV * inflammatory breast cancer * Severe chronic disease
Where this trial is running
Beijing, Beijing Municipality
- Peking University People'S Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shu Wang, doctor — Peking University People's Hospital
- Study coordinator: Chaobin Wang
- Email: hzwcb1990@163.com
- Phone: +86 010 88324010
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.