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

March 14, 2013 updated by: Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
        • Sub-Investigator:
          • Ying Yan, MD
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Qiang Sun, MD
        • Sub-Investigator:
          • Changjun Wang, MD
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Sub-Investigator:
          • Donggui Wan, MD
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Binghe Xu, M.D., Ph.D
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital
        • Principal Investigator:
          • Guangyu An, MD
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Hospital of the Ministry of Health
        • Contact:
        • Principal Investigator:
          • Yongqiang Zhang, MD
        • Sub-Investigator:
          • Li Ding, MD
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Cancer Hospital
        • Contact:
          • Hongxue Wang, MD
          • Phone Number: +86-13978806626
        • Principal Investigator:
          • Wei Wei, MD
        • Sub-Investigator:
          • Hongxue Wang, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Qingyuan Zhang, MD
        • Contact:
          • Qingyuan Zhang, MD
          • Phone Number: 86-451-86298800
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Shujun Yang, MD
        • Sub-Investigator:
          • Min Yan, MD
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Recruiting
        • First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Sub-Investigator:
          • Weiwei Gong, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • International Peace Maternity & Child Health Hospital Of The China Welfare Institute
        • Contact:
          • Qi He, MD
          • Phone Number: +86-13801858957
        • Principal Investigator:
          • Qi He, MD
      • Shanghai, Shanghai, China, 200062
        • Recruiting
        • Shanghai Putuo District Center Hospital
        • Contact:
          • Qi Zhu, MD
          • Phone Number: +86-13301679760
        • Principal Investigator:
          • Miaoqian Liang, MD
        • Sub-Investigator:
          • Qi Zhu, MD
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
          • Duo Ni, MD
          • Phone Number: +86-13909926820
        • Principal Investigator:
          • Duo Ni, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jufen Cai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Etoposide
Etoposide Capsules
Drug: Etoposide
Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
Other Names:
  • Lastet, VP-16

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Zhejiang Cancer Hospital
Peking Union Medical College Hospital
Henan Cancer Hospital
Peking University Cancer Hospital & Institute
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
Harbin Medical University
The First Affiliated Hospital of Dalian Medical University
Xinjiang Medical University
International Peace Maternity and Child Health Hospital
Shanghai Putuo District Center Hospital
Beijing Hospital of the Ministry of Health
Guangxi Cancer Hospital

Investigators

  • Principal Investigator: Binghe Xu, M.D., Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (ESTIMATE)

December 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-BC-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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