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

Sponsor: Sun Yat-sen University
Study ID: NCT02362958
Phase: PHASE2
Status: Completed

Conditions

HER2 Positive Breast Cancer

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Key Dates

Start date: Jan 9, 2015
Status verified: Jul 2020
Primary completion: May 31, 2020
Completion: May 31, 2020

Study Design

Enrollment: 159 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Lapatinib and Capecitabine or Vinorelbine
Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)

Primary Outcome Measure

progression-free survival [ Time Frame: 36 months ]