Neoadjuvant therapy guided by drug screening for HER2 positive early breast cancer
Official title: Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for HER2 Positive Early Breast Cancer Patients
Run by Peking University People's Hospital · NCT04750122 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 46 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 28, 2021 |
| Main results expected | June 30, 2022 |
| Study ends | December 31, 2026 |
| Registry record updated | April 1, 2021 |
| Trial ID | NCT04750122 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕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 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.
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 gone: Previous studies have shown promising results using similar in vitro drug sensitivity screening methods, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy
This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.
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Comparing two chemotherapy regimens for HER2-positive early breast cancer
This study is testing two different chemotherapy treatments to see which one works better for women with early-stage HER2-positive breast cancer after surgery.
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Neoadjuvant therapy for HER2-positive early breast cancer
This study is testing if a new drug called trastuzumab-deruxtecan can work better than standard chemotherapy for people with early HER2-positive breast cancer to see if it helps them respond better to treatment.
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.