Breast CancerPhase 2NCT01492556
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
A Phase 2 study testing Etoposide in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Etoposide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesChina
- Study dates
- Dec 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Beijing Hospital of the Ministry of Health
Beijing, Beijing Municipality, 100005
Li Ding, MD, +86-13701314630, zhangygqg@yahoo.com.cn
Yongqiang Zhang, MD
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Changjun Wang, MD, +86-10-6915-8936, wangchangjun.cannei@gmail.com
Qiang Sun, MD
- Recruiting
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020
Dan Yu, MD, +86-13810292522, xiaoyugw@126.com
Dan Yu, MD
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peng Yuan, M.D., 86-10-8778-8114, yuanpeng01@hotmail.com
Binghe Xu, M.D., Ph.D
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Donggui Wan, MD, +86-13601365686, dongguiwan@263.net
Liqun Jia, MD
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Ying Yan, MD, +86-13141316976, yan99640815@yahoo.com.cn
Lijun Di, MD
- Recruiting
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Weiwei Gong, MD, +86-18941197930, gongweiwei12@163.com
Li Li, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jufen Cai, MD, +86-13867168680, CaiJf108@126.com
Jufen Cai, MD
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyuan Zhang, MD, 86-451-86298800
Qingyuan Zhang, MD
- Recruiting
Guangxi Cancer Hospital
Nanning, Guangxi, 530021
Hongxue Wang, MD, +86-13978806626
Wei Wei, MD
- Recruiting
International Peace Maternity & Child Health Hospital of the China Welfare Institute
Shanghai, Shanghai Municipality, 200030
Qi He, MD, +86-13801858957
Qi He, MD
- Recruiting
Shanghai Putuo District Center Hospital
Shanghai, Shanghai Municipality, 200062
Qi Zhu, MD, +86-13301679760
Miaoqian Liang, MD
- Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Duo Ni, MD, +86-13909926820
Duo Ni, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Min Yan, MD, +86-13673641112, ym200678@126.com
Shujun Yang, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Etoposide
- Keywords
- Recurrent, Metastatic, Breast cancer
- Medical subject headings
- Breast Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called Lastet, VP-16
Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Etoposide | Experimental | Etoposide Capsules Receives: Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Up to 1 year
Secondary outcomes (4)
Clinical response rate
Assessed by RECIST v1.1 criteria.
Measured: Every six weeks
1-year survival rate
Measured: Up to 1 year
Adverse events
Measured: Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year
Quality of Life
Measured: Every six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, 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, The Second Affiliated Hospital of 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
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, M.D., Ph.D, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492556
- Sponsor's protocol ID
- CH-BC-015
- Status last verified
- Mar 2013
- First submitted
- 12 Dec 2011
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01492556
- Acronym / sponsor ID
- CH-BC-015
- Conditions
- Breast Cancer
- Keywords
- Recurrent, Metastatic, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, 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, The Second Affiliated Hospital of 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
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etoposide | Experimental | Drug: EtoposideEtoposide Capsules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoposideAlso: Lastet, VP-16Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd. | Drug | Etoposide |
Primary outcome
Progression-free survival
Time frame: Up to 1 year
4 secondary outcomes
Clinical response rate
Time frame: Every six weeks
1-year survival rate
Time frame: 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
Quality of Life
Time frame: Every six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binghe Xu, M.D., Ph.D principal investigator
Chinese Academy of Medical Sciences
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Yuan, M.D. (86-10-8778-8114, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.