Clinical trial · Interventional
A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Sun Yat-sen University Cancer Center
NCT02362958CI-TRIAL-00045974completedPhase 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)
Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive 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 |
|---|---|---|---|
| HER2 Positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lapatinib and capecitabine or vinorelbine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib and Capecitabine or Vinorelbine
- description
- Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)
- interventionNames
- Drug: lapatinib and capecitabine or vinorelbine
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 36 months
- description
- The time from randomization to disease progression or death from any causes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * HER2-expressing primary or metastatic tumor * Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care. * Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Normal organ function, including bone marrow function, renal function, liver function, and cardiac function * Signed and dated an informed consent form * Life expectancy of at least 12 weeks Exclusion Criteria: * Pregnant or breast feeding * left ventricular ejection fraction (LVEF) \< 45% by echocardiogram * Disease-free interval (DFI) less than 12 months * Uncontrolled medical problems * Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin * Patients were unable or unwilling to comply with program requirements
References
Publications (1)
- DERIVEDDuan F, Zhong M, Ma Y, Song C, Zhang L, Lin Y, Wu Z, Zhang Y, Huang J, Xu F, Shi Y, Wang S, Yuan Z, Xia W, Bi X. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: a phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022 Mar 15;22(1):271. doi: 10.1186/s12885-022-09399-2. PMID 35291977