A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant Chemotherapy

Sponsor
Fudan University
Study ID
NCT04302441
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
    vinorelbine 25mg/m2 on day 1 and 8,every 3 weeks
  • Capecitabine — DRUG
    Capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle

Study Details

This study aims to evaluate vinorelbine plus capecitabine combined with trastuzumab versus trastuzumab alone as the adjuvant Treatment of HER2 positive patients following neoadjuvant chemotherapy

Key Dates

Start date
Nov 10, 2016
Status verified
Mar 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

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

Arms

  • Experimental: NXH group
    Patients should receive four cycles of NXH regimen (vinorelbine at 25 mg/m2 iv infusion on day 1 and day 8 plus capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle, trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year).
  • No Intervention: H group
    Patients should receive trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year.

Primary Outcome Measure

Disease free survival [ Time Frame: 3 year ]

Central Contacts

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