A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT03939871
Phase
PHASE2
Status
Unknown

Conditions

  • Hormone Receptor Positive Advanced Breast Cancer

Eligibility Criteria

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

Interventions

  • fluvestrant + oral vinorelbine — DRUG
    Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity

Study Details

This is a single-center phase II study designed to evaluated the efficacy and safety of fulvestrant in combination with oral vinorelbine in hormone receptor-positive advanced breast cancer

Key Dates

Start date
Dec 12, 2017
Status verified
Jun 2020
Primary completion
Dec 12, 2020
Completion
Dec 12, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Fluvestrant in combination with oral Vinorelbine Fluvestrant: administered at a dose of 0.5g once im every 28 days. Vinorelbine: administered at a dose of 60mg/kg once a week for 3 weeks p.o. every 28 days.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: approximately 1.5 years ]

Central Contacts