Clinical trial · Observational
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer: A Real World Study
NCT04899128CI-TRIAL-00051949unknownClinicalTrials.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 multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Observational Group
- description
- Patients receive pyrotinib-based therapy after lapatinib progression.
- interventionNames
- Drug: Pyrotinib
Primary outcomes (2)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2 years
- description
- Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female and 18-70 years old * Metastatic or locally recurrent HER2-positive breast cancer * Patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis * Complete and accurate medical data Exclusion Criteria: \- Incomplete medical data
References
Publications (1)
- DERIVEDHua Y, Li W, Jin N, Cai D, Sun J, Sun C, Yang F, Wu X, Huang X, Wang B, Yin Y. Treatment with pyrotinib-based therapy in lapatinib-resistant HER2-positive metastatic breast cancer: a multicenter real-world study. Ther Adv Med Oncol. 2022 Mar 24;14:17588359221085232. doi: 10.1177/17588359221085232. eCollection 2022. PMID 35356262