Clinical trial · Interventional
A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer
Pyrotinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:a Randomised, Double-blind, Multicentre, Phase 3 Trial
- 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)
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, double blind, active-controlled, parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and trastuzumab. Patients will be randomized in a 2:1 ratio to one of the following treatment arms: Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Arm B: placebo (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion. Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment.
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 Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| placebo | Drug | — | UNRESOLVED |
| pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- arm 1
- description
- pyrotinib plus capecitabine pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
- interventionNames
- Drug: pyrotinib
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- arm 2
- description
- placebo plus capecitabine placebo(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
- interventionNames
- Drug: placebo
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥18 and ≤75 years. 2. ECOG performance status of 0 to 1. 3. Life expectancy of more than 12 weeks. 4. According to RECIST 1.1, at least one measurable lesion exists 5. Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies. 6. Prior treatment with trastuzumab(≥2 cycles in the metastatic setting, or ≥3 months in adjuvant setting), and the patients are not available for the trastuzumab or lapatinib 7. Previously reveived both Anthracyclin and Taxane. 8. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L; Platelet count: ≥ 90 x 10\^9/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2 x ULN(patients with liver metastases: \</= 5 x ULN); BUN and Creatinine: ≤ 1.5 x ULN;LVEF: ≥ 50%;QTcF: \< 470 ms. 9. Signed informed consent Exclusion Criteria: 1. Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor. 2. Received previous therapy with capecitabine. 3. History of receiving chemotherapy, target-therapy or investigational treatment within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization. 4. Brain metastases that are untreated, symptomatic, or require therapy to control symptoms. 5. Current severe, uncontrolled systemic disease. 6. Unable or unwilling to swallow tablets.
References
Publications (0)
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