Clinical trial · Interventional
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer: a Single-arm, Ahead, Open-label Study
- 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)
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Diseases | — | UNRESOLVED | — |
| Neoplasm, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
- interventionNames
- Drug: Pyrotinib
- Drug: Trastuzumab
- Drug: Docetaxel
- Drug: Carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
- interventionNames
- Drug: Trastuzumab
- Drug: Docetaxel
- Drug: Carboplatin
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. female patients, 18 years ≤ age ≤ 80 years； 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 3. Histologically confirmed invasive breast cancer（early stage or locally advanced） 4. HER2 positive (HER2+++ by IHC or FISH+) 5. Known hormone receptor status. 6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO 7. Signed informed consent form (ICF) Exclusion Criteria: 1. Metastatic disease (Stage IV) or inflammatory breast cancer 2. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix. 3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. Unable or unwilling to swallow tablets.
References
Publications (1)
- DERIVEDDing Y, Mo W, Xie X, Wang O, He X, Zhao S, Gu X, Liang C, Qin C, Ding K, Yang H, Ding X. Neoadjuvant Pyrotinib plus Trastuzumab, Docetaxel, and Carboplatin in Early or Locally Advanced Human Epidermal Receptor 2-Positive Breast Cancer in China: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Oncol Res Treat. 2023;46(7-8):303-311. doi: 10.1159/000531492. Epub 2023 Jun 9. PMID 37302393