Clinical trial · Interventional
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for HER2 Positive Early Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. 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 metheod for omitting chemotherapy for her2 positive participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Early Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy base on PTC drug screenning
- description
- Patients will receive neoadjuvant therapy including trastuzumab, pertuzumab, and chemotherapy based on PTC drug screening.
- interventionNames
- Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning
Primary outcomes (1)
- measure
- pathological complete response(pCR)
- timeFrame
- up to 12 weeks
- description
- ypT0/is, ypN0
Secondary outcomes (3)
- measure
- event-free survival (EFS)
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * invasive breast cancer * HER2 positive * T2 or node positive * ECOG 0-1 Exclusion Criteria: * stage IV * inflammatory breast cancer * Severe chronic disease
References
Publications (0)
Data not yet available