Breast CancerPhase 2NCT00465673
Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
A Phase 2 study testing Liposomal Doxorubicin in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
Trial summary
Primary objective: To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis Secondary objectives: 1. To determine the overall objective response rate (ORR) 2. To determine the progression free survival, and duration of objective response 3. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Liposomal Doxorubicin
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2005to Jul 2009
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proved breast cancer
- Relapse/recurrent brain metastasis progression after brain radiotherapy
- Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI)
- Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed
- Performance status of ECOG 0, 1, 2
- With normal left ventricular ejection fraction and normal ventricular contractility
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- Age 21 years or older
- Life expectancy equal or longer than 3 months
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin
- Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study
- Prior liposomal doxorubicin treatment
- Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- Brain metastases defined as meninges metastases
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- Presence of serious concomitant illness which might be aggravated by study medication:
- Uncontrolled infection (active serious infections that are not controlled by antibiotics)
- Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
- History of ventricular arrhythmia or congestive heart failure.
- Presence of abnormal left ventricular ejection fraction
- Hematopoietic function as defined below:
- Hemoglobin<10g/dl
- ANC< 1,500/uL
- Platelets<100,000/uL
- Organ function as defined below:
- Total bilirubin >1.5 × ULN
- ALT / AST>3 × ULN (>5.0 x ULN if hepatic metastasis)
- Creatinine >1.5 × ULN
- Mental status is not fit for clinical trial
- Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Johns Hopkins Singapore International Medical Center
Singapore, 308433
About this study
Official title: A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Primary objective:
To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Secondary objectives:
- To determine the overall objective response rate (ORR)
- To determine the progression free survival, and duration of objective response
- To evaluate the overall survival (OS)
- To assess the safety profiles
Read the detailed description
This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design.
Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal.
Recruitment period: 10 months
- Conditions
- Breast Cancer
- Being tested
- Liposomal Doxorubicin
- Keywords
- breast cancer, brain metastatsis, Lipo-Dox
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal DoxorubicinDrug
40mg/m2 over 1 hour infusion for 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Measured: 3 years
Secondary outcomes (4)
To determine the overall objective response rate
Measured: 3 years
To determine the progression free survival, and duration of objective response
Measured: 3 years
To evaluate the overall survival
Measured: 3 years
To assess the safety profiles
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Low recruitment
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.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TTY Biopharm
- Investigators
- Alex Chang, Principal investigator, Johns Hopkins SIngapore International Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465673
- Sponsor's protocol ID
- JS 0553
- Status last verified
- Aug 2009
- First submitted
- 23 Apr 2007
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
- ClinicalTrials.gov ID
- NCT00465673
- Acronym / sponsor ID
- JS 0553
- Conditions
- Breast Cancer
- Keywords
- breast cancer, brain metastatsis, Lipo-Dox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- TTY Biopharm
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Apr 2007 (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.
Primary objective:
To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Secondary objectives:
- To determine the overall objective response rate (ORR)
- To determine the progression free survival, and duration of objective response
- To evaluate the overall survival (OS)
- To assess the safety profiles
Detailed description
This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design.
Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal.
Recruitment period: 10 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically proved breast cancer
- Relapse/recurrent brain metastasis progression after brain radiotherapy
- Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI)
- Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed
- Performance status of ECOG 0, 1, 2
Key exclusion criteria (21 listed)
- Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin
- Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study
- Prior liposomal doxorubicin treatment
- Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
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 |
|---|---|---|
| Liposomal Doxorubicin40mg/m2 over 1 hour infusion for 21 days | Drug | – |
Primary outcome
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Time frame: 3 years
4 secondary outcomes
To determine the overall objective response rate
Time frame: 3 years
To determine the progression free survival, and duration of objective response
Time frame: 3 years
To evaluate the overall survival
Time frame: 3 years
To assess the safety profiles
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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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.
Alex Chang principal investigator
Johns Hopkins SIngapore International Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Doxorubicin in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
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 9 inclusion and 21 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: stopped early, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis (time frame: 3 years). 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 6 Aug 2009.