Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

Sponsor
Henan Cancer Hospital
Study ID
NCT05296577
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anlotinib and vinorelbine — DRUG
    anlotinib 12mg orally ,2 weeks on/1 week off ,Q3W; vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.
  • Vinorelbine injection — DRUG
    vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.

Study Details

The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with vinorelbine in the treatment of HER2- advanced breast cancer.

Key Dates

Start date
Mar 22, 2022
Status verified
Sep 2023
Primary completion
Sep 1, 2024
Completion
Dec 1, 2024

Study Design

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

Arms

  • Experimental: anlotinib and vinorelbine
    anlotinib combined with vinorelbine
  • Placebo Comparator: vinorelbine
    placebo and vinorelbine

Primary Outcome Measure

PFS [ Time Frame: up to 24 months ]

Central Contacts

Related Studies