Sun Yat-sen University Cancer Center
| Registry | NCT02362958 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 159 (Actual) |
| Sponsor | Sun Yat-sen University (Other) |
| Conditions | HER2 Positive Breast Cancer |
| Interventions | lapatinib and capecitabine or vinorelbine (Drug) |
| Dates | start 2015-01-09, primary completion 2020-05-31, completion 2020-05-31, first posted 2015-02-13, last updated 2020-07-15 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for HER2 Positive Breast Cancer All trials of lapatinib and capecitabine or vinorelbine
Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.
Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Lapatinib and Capecitabine or Vinorelbine | Experimental | Drug: lapatinib and capecitabine or vinorelbine | Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8) |
Sex: Female, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong | China |