Clinical trial · Interventional
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
- 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 randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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
- arm1
- description
- Pyrotinib Plus trastuzumab and docetaxel
- interventionNames
- Drug: Pyrotinib
- Drug: Trastuzumab
- Drug: Docetaxel
- type
- PLACEBO_COMPARATOR
- label
- arm2
- description
- placebo plus trastuzumab and docetaxel
- interventionNames
- Drug: Placebo Oral Tablet
- Drug: Trastuzumab
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * female patients, 18 years ≤ age ≤ 75 years； * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter * HER2 positive (HER2+++ by IHC or FISH+) * Known hormone receptor status. * Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO * Signed informed consent form (ICF) Exclusion Criteria: * metastatic disease (Stage IV) or inflammatory breast cancer * 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. * clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); * Unable or unwilling to swallow tablets.
References
Publications (1)
- DERIVEDWu J, Jiang Z, Liu Z, Yang B, Yang H, Tang J, Wang K, Liu Y, Wang H, Fu P, Zhang S, Liu Q, Wang S, Huang J, Wang C, Wang S, Wang Y, Zhen L, Zhu X, Wu F, Lin X, Zou J. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med. 2022 Dec 27;20(1):498. doi: 10.1186/s12916-022-02708-3. PMID 36575513