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

Study Overview
=================
Brief Summary
-----------------
This is a phase IV, single-center, prospective, open-label, randomized,controlled study

Official Title
-----------------
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

Conditions
-----------------
Primary Breast Cancer

Intervention / Treatment
-----------------
* Drug: Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 without radiotherapy and chemotherapy contraindication Adequate hematologic function with: Absolute neutrophil count (ANC) ≥1500/mm3 Platelets ≥100,000/ mm3 Hemoglobin ≥10 g/dL Adequate hepatic and renal function with: Serum bilirubin ≤1.5×UNL Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis) BUN between 1.7 and 8.3 mmol/L Cr between 40 and 110 umol/L Knowledge of the investigational nature of the study and Ability to give informed consent Ability and willingness to comply with study procedures. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br> | Drug: Vinorelbine<br>* different from primary chemotherapy(containing anthracycline or paclitaxel)<br>* Other names: Intensive treatment;|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distant disease-free survival (DDFS) |  | 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse-free survival（RFS）、overall survival（OS） |  | 5 years after surgery |