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

Phase 4

Recruiting

• Conditions: Primary Breast Cancer
• Interventions: Drug: Vinorelbine

• Registration Number: NCT03270007
• Lead Sponsor: Tao OUYANG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2017-11-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 304

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Vinorelbine	-

Primary Outcome Measures

Name	Time	Method
distant disease-free survival (DDFS)	5 years after surgery

Secondary Outcome Measures

Name	Time	Method
relapse-free survival（RFS）、overall survival（OS）	5 years after surgery

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China