NCT01492556

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

2.5 years

First QC Date

December 12, 2011

Last Update Submit

March 14, 2013

Conditions

Breast Cancer

Keywords

RecurrentMetastaticBreast cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Up to 1 year

Secondary Outcomes (4)

  • Clinical response rate

    Every six weeks

  • 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

Study Arms (1)

Etoposide

EXPERIMENTAL

Etoposide Capsules

Drug: Etoposide

Interventions

EtoposideDRUG

Lastet (Etoposide Capsules, 25mg\*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.

Also known as: Lastet, VP-16
Etoposide

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Beijing Hospital of the Ministry of Health

Beijing, Beijing Municipality, 100005, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Beijing Chao-yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Guangxi Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

International Peace Maternity & Child Health Hospital of the China Welfare Institute

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai Putuo District Center Hospital

Shanghai, Shanghai Municipality, 200062, China

RECRUITING

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsRecurrenceNeoplasm Metastasis

Interventions

Etoposide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Binghe Xu, M.D., Ph.D

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

86-10-8778-8114yuanpeng01@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Department of Medical Oncology

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 15, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

CN(14)