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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Drug: Vinorelbine

• Study Type: Interventional
• Enrollment (Anticipated): 304
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xing Wang, MD; Phone Number: 8018 0086-10-88271119; Email: wangxing_susu@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Contact: Xing Wang, MD; Phone Number: 8018 0086-10-88271119; Email: wangxing_susu@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Chemotherapy	Drug: Vinorelbine; different from primary chemotherapy(containing anthracycline or paclitaxel); Other Names: Intensive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
distant disease-free survival (DDFS)	5 years after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
relapse-free survival（RFS）、overall survival（OS）	5 years after surgery

Collaborators and Investigators

• Sponsor: Tao OUYANG
• Investigators: Principal Investigator: Xing Wang, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: BCP19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No