Clinical trial · Interventional
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
NCT03847818CI-TRIAL-00037395unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
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 Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib+Trastuzumab+Docetaxel+Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
- interventionNames
- Drug: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
Primary outcomes (1)
- measure
- Percentage of Participants With Pathological Complete Response (pCR)
- timeFrame
- through study completion, an average of 1 year
Secondary outcomes (4)
- measure
- Event-free survival
- timeFrame
- Following surgery until Year 3
- measure
- Disease-free Survival
- timeFrame
- Following surgery until Year 3
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. female patients, 18 years ≤ age ≤75 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 (0)
Data not yet available
No reference posted for this study.