Clinical trial · Observational
Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer
Real World Study of Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for Trastuzumab Resistant HER2-positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
NCT05764941CI-TRIAL-00065024unknownClinicalTrials.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 real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic 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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inetetamab | Drug | — | UNRESOLVED |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Observational Group
- description
- Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.
- interventionNames
- Drug: Inetetamab
- Drug: Pyrotinib
- Drug: Vinorelbine
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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female and 18-80 years old; 2. The patient was diagnosed as HER2-positive breast cancer by histopathology (HER2 positive (IHC +++ or IHC++ but FISH/CISH+ )); 3. All patients have previously received ≤ 2 lines chemotherapy for metastatic breast cancer; 4. Patients received inetetamab combined with pyrotinib and vinorelbine after trastuzumab failure; 5. According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated; 6. ECOG score of physical status was less than 2, and the expected survival time was not less than 3 months; 7. Complete and traceable medical data. Exclusion Criteria: 1. Incomplete medical data; 2. The investigator believes that the patient is not suitable to enter this study.
References
Publications (0)
Data not yet available
No reference posted for this study.