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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01492556
• Other study ID #: CH-BC-015
• Status: Recruiting
• Phase: Phase 2
• First received: December 12, 2011
• Last updated: March 14, 2013
• Start date: December 2011
• Est. completion date: June 2015

Study information

• Verified date: March 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, M.D.
• Phone: 86-10-8778-8114
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Etoposide
Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital	Beijing	Beijing
China	Beijing Hospital of the Ministry of Health	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Cancer Hospital	Beijing	Beijing
China	First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Guangxi Cancer Hospital	Nanning	Guangxi
China	International Peace Maternity & Child Health Hospital of the China Welfare Institute	Shanghai	Shanghai
China	Shanghai Putuo District Center Hospital	Shanghai	Shanghai
China	Affiliated Cancer Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (14)

Lead Sponsor

Collaborator

Chinese Academy of Medical Sciences

Beijing Cancer Hospital, Beijing Chao Yang Hospital, Beijing Hospital of the Ministry of Health, China-Japan Friendship Hospital, Guangxi Cancer Hospital, Harbin Medical University, Henan Cancer Hospital, International Peace Maternity and Child Health Hospital, Peking Union Medical College Hospital, Shanghai Putuo District Center Hospital, The First Affiliated Hospital of Dalian Medical University, Xinjiang Medical University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Up to 1 year	No
Secondary	Clinical response rate	Assessed by RECIST v1.1 criteria.	Every six weeks	No
Secondary	1-year survival rate		Up to 1 year	No
Secondary	Adverse events		Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year	Yes
Secondary	Quality of Life		Every six weeks	No