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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tao OUYANG
• Treatments: Hormones; Mitogens; Vinorelbine

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:

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