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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Etoposide

• Registration Number: NCT01492556
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-15
• Primary Completion: 2014-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etoposide	Etoposide	Etoposide Capsules

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Clinical response rate	Every six weeks	Assessed by RECIST v1.1 criteria.
1-year survival rate	Up to 1 year
Adverse events	Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year
Quality of Life	Every six weeks

Trial Locations

Locations (14)

Beijing Hospital of the Ministry of Health; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, 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

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Chao-yang Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Guangxi Cancer Hospital; 🇨🇳 Nanning, Guangxi, China