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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03270007
Other study ID # BCP19
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 10, 2017
Est. completion date December 31, 2024

Study information

Verified date October 2020
Source Peking University
Contact Xing Wang, MD
Phone 0086-10-88271119
Email wangxing_susu@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 304
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 66 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vinorelbine
different from primary chemotherapy(containing anthracycline or paclitaxel)

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Tao OUYANG

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary distant disease-free survival (DDFS) 5 years after surgery
Secondary relapse-free survival(RFS)?overall survival(OS) 5 years after surgery
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