Primary Breast Cancer
Conditions
Brief summary
This is a phase IV, single-center, prospective, open-label, randomized,controlled study
Interventions
DRUGVinorelbine
different from primary chemotherapy(containing anthracycline or paclitaxel)
Sponsors
Tao OUYANG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 66 Years
Healthy volunteers
No
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: 1. Absolute neutrophil count (ANC) ≥1500/mm3 2. Platelets ≥100,000/ mm3 3. Hemoglobin ≥10 g/dL * Adequate hepatic and renal function with: 1. Serum bilirubin ≤1.5×UNL 2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis) 3. BUN between 1.7 and 8.3 mmol/L 4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| distant disease-free survival (DDFS) | 5 years after surgery |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival（RFS）、overall survival（OS） | 5 years after surgery |
Countries
China
Contacts
Primary ContactXing Wang, MD
Backup ContactYing-jian He, MD
Outcome results
None listed