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

Primary Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270007
• Other study ID #: BCP19
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Primary Breast Cancer

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