Clinical trial · Interventional
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab
- 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 pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm Pyrotinib
- description
- Intervention: Drug: Pyrotinib
- interventionNames
- Drug: Pyrotinib
- type
- PLACEBO_COMPARATOR
- label
- Arm Placebo
- description
- Intervention: Drug: Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Invasive Disease-free Survival (iDFS)
- timeFrame
- From randomization until time of event up to 2 years
- description
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 HER2 positive breast cancer. * Known hormone receptor status. * Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram. * Been treated for early breast cancer with standard of care duration of trastuzumab. * If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response. * Signed informed consent form (ICF) . Exclusion Criteria: * Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. * History of heart disease. * Bilateral breast cancer. * Corrected QT (QTc) interval ≥0.47 seconds. * History of gastrointestinal disease with diarrhea as the major symptom.
References
Publications (0)
Data not yet available