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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 Purpose

Primary Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vinorelbine
Sponsored by
Tao OUYANG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Breast Cancer

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chemotherapy

Control

Arm Description

Outcomes

Primary Outcome Measures

distant disease-free survival (DDFS)

Secondary Outcome Measures

relapse-free survival（RFS）、overall survival（OS）

Full Information

First Posted
August 30, 2017
Last Updated
October 26, 2020
Sponsor
Tao OUYANG
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1. Study Identification

Unique Protocol Identification Number
NCT03270007
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao OUYANG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Intensive treatment
Intervention Description
different from primary chemotherapy(containing anthracycline or paclitaxel)
Primary Outcome Measure Information:
Title
distant disease-free survival (DDFS)
Time Frame
5 years after surgery
Secondary Outcome Measure Information:
Title
relapse-free survival（RFS）、overall survival（OS）
Time Frame
5 years after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xing Wang, MD
Phone
0086-10-88271119
Ext
8018
Email
wangxing_susu@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-jian He, MD
Phone
0086-10-88271119
Ext
8018
Email
mimi487@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xing Wang, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xing Wang, MD
Phone
0086-10-88271119
Ext
8018
Email
wangxing_susu@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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