Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT05747326
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • oral vinorelbine and capecitabine — DRUG
    The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.

Study Details

This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.

Key Dates

Start date
Jan 1, 2022
Status verified
Feb 2023
Primary completion
Jun 1, 2023
Completion
Jun 30, 2023

Study Design

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

Arms

  • Experimental: Study group
    The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.

Primary Outcome Measure

Progression-free Survival [ Time Frame: At 1 year ]

Central Contacts

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