Back to resultsStudy of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Recurrent, Metastatic, Breast cancer
Eligibility 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.
Sites / Locations
- Beijing Hospital of the Ministry of HealthRecruiting
- Peking Union Medical College HospitalRecruiting
- Beijing Chao-yang HospitalRecruiting
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
- China-Japan Friendship HospitalRecruiting
- Peking University Cancer HospitalRecruiting
- Guangxi Cancer HospitalRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- First Affiliated Hospital of Dalian Medical UniversityRecruiting
- International Peace Maternity & Child Health Hospital of the China Welfare InstituteRecruiting
- Shanghai Putuo District Center HospitalRecruiting
- Affiliated Cancer Hospital of Xinjiang Medical UniversityRecruiting
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etoposide
Arm Description
Etoposide Capsules
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Clinical response rate
Assessed by RECIST v1.1 criteria.
1-year survival rate
Adverse events
Quality of Life
Full Information
NCT ID
NCT01492556
First Posted
December 12, 2011
Last Updated
March 14, 2013
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, 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, The Second Affiliated Hospital of Harbin Medical University, Zhejiang Cancer Hospital, Henan Cancer Hospital, Guangxi Cancer Hospital, Shanghai Putuo District Center Hospital, International Peace Maternity and Child Health Hospital, Xinjiang Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01492556
Brief Title
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
Official Title
A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, 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, The Second Affiliated Hospital of Harbin Medical University, Zhejiang Cancer Hospital, Henan Cancer Hospital, Guangxi Cancer Hospital, Shanghai Putuo District Center Hospital, International Peace Maternity and Child Health Hospital, Xinjiang Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Recurrent, Metastatic, Breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Etoposide
Arm Type
Experimental
Arm Description
Etoposide Capsules
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Lastet, VP-16
Intervention Description
Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Clinical response rate
Description
Assessed by RECIST v1.1 criteria.
Time Frame
Every six weeks
Title
1-year survival rate
Time Frame
Up to 1 year
Title
Adverse events
Time Frame
Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year
Title
Quality of Life
Time Frame
Every six weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, M.D.
Phone
86-10-8778-8114
Email
yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D., Ph.D
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital of the Ministry of Health
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Ding, MD
Phone
+86-13701314630
Email
zhangygqg@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yongqiang Zhang, MD
First Name & Middle Initial & Last Name & Degree
Li Ding, MD
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changjun Wang, MD
Phone
+86-10-6915-8936
Email
wangchangjun.cannei@gmail.com
First Name & Middle Initial & Last Name & Degree
Qiang Sun, MD
First Name & Middle Initial & Last Name & Degree
Changjun Wang, MD
Facility Name
Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Yu, MD
Phone
+86-13810292522
Email
xiaoyugw@126.com
First Name & Middle Initial & Last Name & Degree
Dan Yu, MD
First Name & Middle Initial & Last Name & Degree
Guangyu An, MD
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
Phone
86-10-8778-8114
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Peng Yuan, MD
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donggui Wan, MD
Phone
+86-13601365686
Email
dongguiwan@263.net
First Name & Middle Initial & Last Name & Degree
Liqun Jia, MD
First Name & Middle Initial & Last Name & Degree
Donggui Wan, MD
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
Ying Yan, MD
Phone
+86-13141316976
Email
yan99640815@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Lijun Di, MD
First Name & Middle Initial & Last Name & Degree
Ying Yan, MD
Facility Name
Guangxi Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxue Wang, MD
Phone
+86-13978806626
First Name & Middle Initial & Last Name & Degree
Wei Wei, MD
First Name & Middle Initial & Last Name & Degree
Hongxue Wang, MD
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, MD
Phone
86-451-86298800
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, MD
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, MD
Phone
+86-13673641112
Email
ym200678@126.com
First Name & Middle Initial & Last Name & Degree
Shujun Yang, MD
First Name & Middle Initial & Last Name & Degree
Min Yan, MD
Facility Name
First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Gong, MD
Phone
+86-18941197930
Email
gongweiwei12@163.com
First Name & Middle Initial & Last Name & Degree
Li Li, MD
First Name & Middle Initial & Last Name & Degree
Weiwei Gong, MD
Facility Name
International Peace Maternity & Child Health Hospital of the China Welfare Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi He, MD
Phone
+86-13801858957
First Name & Middle Initial & Last Name & Degree
Qi He, MD
Facility Name
Shanghai Putuo District Center Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD
Phone
+86-13301679760
First Name & Middle Initial & Last Name & Degree
Miaoqian Liang, MD
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duo Ni, MD
Phone
+86-13909926820
First Name & Middle Initial & Last Name & Degree
Duo Ni, MD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jufen Cai, MD
Phone
+86-13867168680
Email
CaiJf108@126.com
First Name & Middle Initial & Last Name & Degree
Jufen Cai, MD
12. IPD Sharing Statement
Learn more about this trial
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
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