Study of Apatinib Combined With Oral Vinorelbine in Metastatic HER2 Negative Breast Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT02768415
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral vinorelbine can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.

Key Dates

Start date
Jun 30, 2016
Status verified
Jun 2019
Primary completion
Jan 31, 2018

Study Design

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

Arms

  • Experimental: lapatinib+oral vinorelbine
    apatinib 425/500mg qd, 21days/cycle oral vinorelbine 60mg/m2 d1, 8, 15 21days/cycle\*3cycles, after 3 cycles: 80mg/m2 d1, 8, 15 21days/cycle

Primary Outcome Measure

Progression free survival (PFS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine [ Time Frame: up to 1 year after the last patient enrolled ]

Related Studies