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

Sun Yat-sen University159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

159

Conditions

HER2 Positive Breast Cancer

Interventions

lapatinib and capecitabine or vinorelbineDRUG

lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

progression-free survival

The time from randomization to disease progression or death from any causes

Time frame: 36 months

Data from ClinicalTrials.gov

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