Clinical trial · Interventional
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial
NCT07180082CI-TRIAL-00097399CORIN-PYRArecruitingPhase 2ClinicalTrials.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, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive 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 |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intermittent pyrotinib
- description
- Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days
- interventionNames
- Drug: Pyrotinib
- type
- ACTIVE_COMPARATOR
- label
- Continuous pyroitnib
- description
- oral pyrotinib qd
- interventionNames
- Drug: Pyrotinib
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥18 years old * Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery * Pathologically confirmed HER2+ at least once for either primary or metastatic lesion * Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician * At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1 * ECOG 0-1 * Adequate organ function Exclusion Criteria: * During pregnancy and lactation * Difficulties with pyrotinib administration or absorption
References
Publications (0)
Data not yet available
No reference posted for this study.