Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT03775928
Phase
PHASE2
Status
Unknown

Conditions

  • Triple-negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    apatinib 425mg qd po
  • capecitabine — DRUG
    capecitabine 1000mg/m2 bid d1-d14

Study Details

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer

Key Dates

Start date
Dec 18, 2018
Status verified
Dec 2018
Primary completion
Dec 1, 2020
Completion
Oct 1, 2021

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib + Capecitabine
    Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d
  • Active Comparator: Capecitabine
    capecitabine 1000mg/m2 bid d1-14, q21d

Primary Outcome Measure

progression-free survival [ Time Frame: up to 6 months ]

Central Contacts

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