Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy

Sponsor
Tao OUYANG
Study ID
NCT03270007
Phase
PHASE4
Status
Unknown

Conditions

  • Primary Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 66 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    different from primary chemotherapy(containing anthracycline or paclitaxel)

Study Details

This is a phase IV, single-center, prospective, open-label, randomized,controlled study

Key Dates

Start date
Nov 10, 2017
Status verified
Oct 2020
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Chemotherapy
  • No Intervention: Control

Primary Outcome Measure

distant disease-free survival (DDFS) [ Time Frame: 5 years after surgery ]

Central Contacts