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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Etoposide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoposide<br>Etoposide Capsules | Drug: Etoposide<br>* Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.<br>* Other names: Lastet, VP-16;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate | Assessed by RECIST v1.1 criteria. | Every six weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent, Metastatic, Breast cancer