Breast Cancer
Conditions
Keywords
Recurrent, Metastatic, Breast cancer
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.
Interventions
DRUGEtoposide
Lastet (Etoposide Capsules, 25mg\*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
Sponsors
Peking University Cancer Hospital & Institute
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
Beijing Hospital of the Ministry of Health
The First Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Harbin Medical University
Zhejiang Cancer Hospital
Henan Cancer Hospital
Guangxi Cancer Hospital
Shanghai Putuo District Center Hospital
International Peace Maternity and Child Health Hospital
Xinjiang Medical University
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | Up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactPeng Yuan, M.D.
Outcome results
None listed