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

Phase 2
18 Years
80 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

Binghe Xu, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

June 2015

Related Keywords:

  • Breast Cancer
  • Recurrent
  • Metastatic
  • Breast cancer
  • Breast Neoplasms