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

Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Etoposide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Chinese Academy of Medical Sciences

Official(s) and/or principal investigator(s):
Binghe Xu, M.D., Ph.D, Principal Investigator, Affiliation: Chinese Academy of Medical Sciences

Overall contact:
Peng Yuan, M.D., Phone: 86-10-8778-8114, Email: yuanpeng01@hotmail.com


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.

Clinical Details

Official title: A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome:

Clinical response rate

1-year survival rate

Adverse events

Quality of Life

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.


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


- 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.

Locations and Contacts

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

Beijing Chao-yang Hospital, Beijing, Beijing 100020, China; Recruiting
Dan Yu, MD, Phone: +86-13810292522, Email: xiaoyugw@126.com
Dan Yu, MD, Sub-Investigator
Guangyu An, MD, Principal Investigator

Beijing Hospital of the Ministry of Health, Beijing, Beijing 100005, China; Recruiting
Li Ding, MD, Phone: +86-13701314630, Email: zhangygqg@yahoo.com.cn
Yongqiang Zhang, MD, Principal Investigator
Li Ding, MD, Sub-Investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing 100021, China; Recruiting
Peng Yuan, M.D., Phone: 86-10-8778-8114, Email: yuanpeng01@hotmail.com
Binghe Xu, M.D., Ph.D, Principal Investigator
Peng Yuan, MD, Sub-Investigator

China-Japan Friendship Hospital, Beijing, Beijing 100029, China; Recruiting
Donggui Wan, MD, Phone: +86-13601365686, Email: dongguiwan@263.net
Liqun Jia, MD, Principal Investigator
Donggui Wan, MD, Sub-Investigator

Peking Union Medical College Hospital, Beijing, Beijing 100005, China; Recruiting
Changjun Wang, MD, Phone: +86-10-6915-8936, Email: wangchangjun.cannei@gmail.com
Qiang Sun, MD, Principal Investigator
Changjun Wang, MD, Sub-Investigator

Peking University Cancer Hospital, Beijing, Beijing 100142, China; Recruiting
Ying Yan, MD, Phone: +86-13141316976, Email: yan99640815@yahoo.com.cn
Lijun Di, MD, Principal Investigator
Ying Yan, MD, Sub-Investigator

Guangxi Cancer Hospital, Nanning, Guangxi 530021, China; Recruiting
Hongxue Wang, MD, Phone: +86-13978806626
Wei Wei, MD, Principal Investigator
Hongxue Wang, MD, Sub-Investigator

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang 150081, China; Recruiting
Qingyuan Zhang, MD, Phone: 86-451-86298800
Qingyuan Zhang, MD, Principal Investigator

Henan Cancer Hospital, Zhengzhou, Henan 450008, China; Recruiting
Min Yan, MD, Phone: +86-13673641112, Email: ym200678@126.com
Shujun Yang, MD, Principal Investigator
Min Yan, MD, Sub-Investigator

First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China; Recruiting
Weiwei Gong, MD, Phone: +86-18941197930, Email: gongweiwei12@163.com
Li Li, MD, Principal Investigator
Weiwei Gong, MD, Sub-Investigator

International Peace Maternity & Child Health Hospital of the China Welfare Institute, Shanghai, Shanghai 200030, China; Recruiting
Qi He, MD, Phone: +86-13801858957
Qi He, MD, Principal Investigator

Shanghai Putuo District Center Hospital, Shanghai, Shanghai 200062, China; Recruiting
Qi Zhu, MD, Phone: +86-13301679760
Miaoqian Liang, MD, Principal Investigator
Qi Zhu, MD, Sub-Investigator

Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830011, China; Recruiting
Duo Ni, MD, Phone: +86-13909926820
Duo Ni, MD, Principal Investigator

Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, China; Recruiting
Jufen Cai, MD, Phone: +86-13867168680, Email: CaiJf108@126.com
Jufen Cai, MD, Principal Investigator

Additional Information

Starting date: December 2011
Last updated: March 14, 2013

Page last updated: August 23, 2015

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