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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Beijing Cancer Hospital
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
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
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01492556
First received: December 12, 2011
Last updated: March 14, 2013
Last verified: March 2013
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Drug: Etoposide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rate [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
    Assessed by RECIST v1.1 criteria.

  • 1-year survival rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etoposide
Etoposide Capsules
Drug: Etoposide
Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
Other Name: Lastet, VP-16

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492556

Locations
China, Beijing
Beijing Hospital of the Ministry of Health
Beijing, Beijing, China, 100005
Peking Union Medical College Hospital
Beijing, Beijing, China, 100005
Beijing Chao-yang Hospital
Beijing, Beijing, China, 100020
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
Peking University Cancer Hospital
Beijing, Beijing, China, 100142
China, Guangxi
Guangxi Cancer Hospital
Nanning, Guangxi, China, 530021
China, Heilongjiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Liaoning
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
China, Shanghai
International Peace Maternity & Child Health Hospital of the China Welfare Institute
Shanghai, Shanghai, China, 200030
Shanghai Putuo District Center Hospital
Shanghai, Shanghai, China, 200062
China, Xinjiang
Affiliated Cancer Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830011
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Beijing Cancer Hospital
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
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
Investigators
Principal Investigator: Binghe Xu, M.D., Ph.D Chinese Academy of Medical Sciences
  More Information

Responsible Party: Binghe Xu, Deputy Director of Department of Medical Oncology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01492556     History of Changes
Other Study ID Numbers: CH-BC-015 
Study First Received: December 12, 2011
Last Updated: March 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Recurrent
Metastatic
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 06, 2016