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

Phase 2

Completed

• Conditions: HER2 Positive Breast Cancer
• Interventions: Drug: lapatinib and capecitabine or vinorelbine

• Registration Number: NCT02362958
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2015-01-09
• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lapatinib and Capecitabine or Vinorelbine	lapatinib and capecitabine or vinorelbine	Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)

Primary Outcome Measures

Name	Time	Method
progression-free survival	36 months	The time from randomization to disease progression or death from any causes

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China