Clinical trial NCT01492556: Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
Official title: A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Recurrent
Metastatic
Breast cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Peking University Cancer Hospital & Institute
name: Peking Union Medical College Hospital
name: Beijing Chao Yang Hospital
name: China-Japan Friendship Hospital
name: Beijing Hospital of the Ministry of Health
name: The First Affiliated Hospital of Dalian Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: Zhejiang Cancer Hospital
name: Henan Cancer Hospital
name: Guangxi Cancer Hospital
name: Shanghai Putuo District Center Hospital
name: International Peace Maternity and Child Health Hospital
name: Xinjiang Medical University
First posted: 2011-12-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 1 year
Secondary outcomes:
measure: Clinical response rate
timeFrame: Every six weeks
measure: 1-year survival rate
timeFrame: Up to 1 year
measure: Adverse events
timeFrame: Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year
measure: Quality of Life
timeFrame: Every six weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of the Ministry of Health
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Nanning
country: China
facility: Guangxi Cancer Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: International Peace Maternity & Child Health Hospital of the China Welfare Institute
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
state: Shanghai
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Binghe Xu, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: