Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborators:
Beijing Cancer Hospital
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
Beijing Hospital of the Ministry of Health
The First Affiliated Hospital of Dalian Medical University
Harbin Medical University
Zhejiang Cancer Hospital
Henan Cancer Hospital
Guangxi Cancer Hospital
Shanghai Putuo District Center Hospital
International Peace Maternity & Child Health Hospital of the China Welfare Institute
Xinjiang Medical University
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01492556
First received: December 12, 2011
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether Etoposide Monotherapy is effective and safe in the treatment of recurrent or metastatic breast cancer in Chinese female patients.


Condition Intervention Phase
Breast Cancer
Drug: Etoposide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rate [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
    Assessed by RECIST v1.1 criteria.

  • 1-year survival rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etoposide
Etoposide Capsules
Drug: Etoposide
Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
Other Name: Lastet, VP-16

Detailed Description:

Current recommended dosage of Etoposide in treating breast cancer is 50 mg/m2 orally once a day for 21 days, repeated every 28 days. With retrospective data review, this study intends to adjust Etoposide dose to 60 mg/m2 daily for 10 days, repeated every 21 days as a cycle, to investigate the effectiveness and safety of Etoposide monotherapy in the treatment of recurrent or metastatic breast cancer in Chinese female patients.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-80 years old.
  • ECOG status: 0-2.
  • Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer.
  • No more than three prior chemotherapies, adjuvant chemotherapy excluded.
  • Received prior anthracycline, taxane therapy.
  • At least 4 weeks from previous chemotherapy.
  • Measurable disease of >=2 cm (>=1 cm on spiral CT scan).
  • Life expectancy of ≥ 3 months.
  • Adequate organ functions:

    • Hemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥100×10^9/L,
    • Creatinine clearance ≥60ml/min,
    • Bilirubin ≤1.5 times upper limit of normal (ULN); AKP,AST and ALT ≤2.5x ULN(≤5x ULN if due to liver metastases).
  • Signed informed consent.
  • Menopausal women or received surgical sterilization, women with children potential must not be pregnant or nursing with negative pregnancy test and willing to practice acceptable methods of birth control during the study and 3 months after the study.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Untreated or uncontrolled CNS metastases, or with refractory psychiatric illness.
  • Prior treatment with Etoposide.
  • Other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer.
  • Clinically significant heart diseases (e.g.congestive heart failure, symptomatic coronary disease, uncontrolled cardiac arrhythmia, Myocardial infarction) within the past 12 months.
  • Serious uncontrolled concurrent infection or metabolism disorder.
  • Concurrent treatment for active peptic ulcer disease or with digestive disorders.
  • Prior radiotherapy and major surgery within 3 weeks before screening.
  • Less than 4 weeks since prior investigational agents.
  • Metastases present in more than one-third whole liver.
  • Unable or unwilling to comply with the study protocol.
  • Unsuitable to participate in study, that in the opinion of the treating physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492556

Contacts
Contact: Peng Yuan, M.D. 86-10-8778-8114 yuanpeng01@hotmail.com

Locations
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Peng Yuan, M.D.    86-10-8778-8114    yuanpeng01@hotmail.com   
Principal Investigator: Binghe Xu, M.D., Ph.D         
Sub-Investigator: Peng Yuan, MD         
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Ying Yan, MD    +86-13141316976    yan99640815@yahoo.com.cn   
Principal Investigator: Lijun Di, MD         
Sub-Investigator: Ying Yan, MD         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Changjun Wang, MD    +86-10-6915-8936    wangchangjun.cannei@gmail.com   
Principal Investigator: Qiang Sun, MD         
Sub-Investigator: Changjun Wang, MD         
Beijing Chao-yang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Dan Yu, MD    +86-13810292522    xiaoyugw@126.com   
Sub-Investigator: Dan Yu, MD         
Principal Investigator: Guangyu An, MD         
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Donggui Wan, MD    +86-13601365686    dongguiwan@263.net   
Principal Investigator: Liqun Jia, MD         
Sub-Investigator: Donggui Wan, MD         
Beijing Hospital of the Ministry of Health Recruiting
Beijing, Beijing, China, 100005
Contact: Li Ding, MD    +86-13701314630    zhangygqg@yahoo.com.cn   
Principal Investigator: Yongqiang Zhang, MD         
Sub-Investigator: Li Ding, MD         
China, Guangxi
Guangxi Cancer Hospital Recruiting
Nanning, Guangxi, China, 530021
Contact: Hongxue Wang, MD    +86-13978806626      
Principal Investigator: Wei Wei, MD         
Sub-Investigator: Hongxue Wang, MD         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Qingyuan Zhang, MD    86-451-86298800      
Principal Investigator: Qingyuan Zhang, MD         
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Min Yan, MD    +86-13673641112    ym200678@126.com   
Principal Investigator: Shujun Yang, MD         
Sub-Investigator: Min Yan, MD         
China, Liaoning
First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
Contact: Weiwei Gong, MD    +86-18941197930    gongweiwei12@163.com   
Principal Investigator: Li Li, MD         
Sub-Investigator: Weiwei Gong, MD         
China, Shanghai
Shanghai Putuo District Center Hospital Recruiting
Shanghai, Shanghai, China, 200062
Contact: Qi Zhu, MD    +86-13301679760      
Principal Investigator: Miaoqian Liang, MD         
Sub-Investigator: Qi Zhu, MD         
International Peace Maternity & Child Health Hospital of the China Welfare Institute Recruiting
Shanghai, Shanghai, China, 200030
Contact: Qi He, MD    +86-13801858957      
Principal Investigator: Qi He, MD         
China, Xinjiang
Affiliated Cancer Hospital of Xinjiang Medical University Recruiting
Urumqi, Xinjiang, China, 830011
Contact: Duo Ni, MD    +86-13909926820      
Principal Investigator: Duo Ni, MD         
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jufen Cai, MD    +86-13867168680    CaiJf108@126.com   
Principal Investigator: Jufen Cai, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
Beijing Hospital of the Ministry of Health
The First Affiliated Hospital of Dalian Medical University
Harbin Medical University
Zhejiang Cancer Hospital
Henan Cancer Hospital
Guangxi Cancer Hospital
Shanghai Putuo District Center Hospital
International Peace Maternity & Child Health Hospital of the China Welfare Institute
Xinjiang Medical University
Investigators
Principal Investigator: Binghe Xu, M.D., Ph.D Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Binghe Xu, Deputy Director of Department of Medical Oncology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01492556     History of Changes
Other Study ID Numbers: CH-BC-015
Study First Received: December 12, 2011
Last Updated: March 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Recurrent
Metastatic
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014