Status:
UNKNOWN
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
Lead Sponsor:
Tao OUYANG
Conditions:
Primary Breast Cancer
Eligibility:
FEMALE
18-66 years
Phase:
PHASE4
Brief Summary
This is a phase IV, single-center, prospective, open-label, randomized,controlled study
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT03270007
Start Date
November 10 2017
End Date
December 31 2024
Last Update
October 28 2020
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142