NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy

Sponsor
Fudan University
Study ID
NCT04307147
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Oral capecitabine (at a dose of 1250 mg/m², twice per day, on days 1 to 14) every 3 weeks for 4 cycles.
  • Vinorelbine — DRUG
    Intravenous vinorelbine (at a dose of 25 mg/m² on day 1, day 8) every 3 weeks for 4 cycles.

Study Details

This is a prospective, randomized, open-lable phase III clinical trial evaluating the effectiveness and safety of vinorelbine plus capecitabine as adjuvant treatment for non-pCR Luminal B breast cancer patients after standard neoadjuvant chemotherapy.

Key Dates

Start date
Jul 3, 2018
Status verified
Mar 2020
Primary completion
Mar 1, 2021
Completion
Sep 1, 2021

Study Design

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

Arms

  • Experimental: NX (vinorelbine and capecitabine )
    Standard therapy plus NX chemotherapy for 4 cycles, (vinorelbine 25 mg/m² d1,8 and capecitabine 1250 mg/m² d1-14, every 3 weeks)
  • No Intervention: Control group
    Standard therapy

Primary Outcome Measure

Disease free survival [ Time Frame: 5-year ]

Related Studies