Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05131841
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cipterbin Combined With Vinorelbine — DRUG
    1. Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer 2. Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

Study Details

To compare pharmacokinetics Index of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

Key Dates

Start date
Jan 4, 2021
Status verified
Nov 2021
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022

Study Design

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

Arms

  • Active Comparator: One-week group
    Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
  • Experimental: Three-week group
    Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

Primary Outcome Measure

Cmax [ Time Frame: From enrollment to 21 days after the last dose administrate ]

Central Contacts

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