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
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.
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 rate1-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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
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.
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
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