Clinical trial · Interventional
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
NCT03412383CI-TRIAL-00031446unknownPhase 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)
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Conditions
Conditions (2)
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 |
| HER2 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 36 months
- description
- From date of first use Pyrotinib until the date of first documented progression or date of death from any cause, whichever came first
Secondary outcomes (6)
- measure
- Adverse events (AEs)
- timeFrame
- up to 36 months
- description
- Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
- measure
- Overall Response rates (ORR)
- timeFrame
- up to 36 months
- description
- Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document. At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV. There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)\>70, life expectancy \> 12 weeks Exclusion Criteria: Lack of adequate organ function as defined below within 2 weeks of registration: Absolute neutrophil count (ANC)\<1.5×109/L，platelet counts (PLT)\<75×109/L or hemoglobin (Hb)\<100g/L Total bilirubin (TBiL)\>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2.5×ULN（or\>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)\>2.5×ULN; serum creatinine concentration (Scr)\>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias. Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy. Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail
References
Publications (1)
- DERIVEDYi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0. PMID 39648226