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

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

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

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