A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer

Study Overview
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Brief Summary
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Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

Detailed Description
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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.

Official Title
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Sun Yat-sen University Cancer Center

Conditions
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HER2 Positive Breast Cancer

Intervention / Treatment
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* Drug: lapatinib and capecitabine or vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lapatinib and Capecitabine or Vinorelbine<br>Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8) | Drug: lapatinib and capecitabine or vinorelbine<br>* lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)<br>* Other names: Tykerb; Xeloda;NVB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | The time from randomization to disease progression or death from any causes | 36 months |