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

Tao OUYANG1 site in 1 country304 target enrollmentNovember 10, 2017

InterventionsVinorelbine

Overview

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

Registry

clinicaltrials.gov

Start Date

November 10, 2017

End Date

December 31, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Tao OUYANG

Responsible Party

Sponsor Investigator

Principal Investigator

Tao OUYANG

Chairman of Breast Center

Peking University

•Female patients, 18≦age ≦66 years
•Biopsy proven lymph node positive, estrogen receptor\<10%、progesterone receptor \<10% and human epidermal growth factor receptor-2 negative primary breast cancer
•Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)
•Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
•Postoperative residual positive lymph nodes
•Adequate recovery from recent surgery
•No history of other malignancies
•No currently uncontrolled diseased or active infection
•Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
•Adequate cardiovascular function reserve with a myocardial infarction within the past six month

•Known or suspected distant metastases
•Concurrent malignancy or history of other malignancy
•Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
•Geographical, social, or psychological problems that would compromise study compliance
•Known or suspected hypersensitivity to vinorelbine