Metastatic Breast CancerPhase 2NCT00380835
Study of Amrubicin With or Without Herceptin in Patients With Metastatic Breast Cancer
A Phase 2 study testing Amrubicin in people with Metastatic Breast Cancer, run by Celgene Corporation at 28 sites in United States.
Trial summary
The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Amrubicin
- How many people
- 66 participants
- Where
- 28 sitesUnited States
- Study dates
- Start not givento Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of breast cancer.
- Metastatic or recurrent disease, either HER2+ (FISH+ or 3+ IHC) or HER2-.
- Maximal dose of prior adjuvant anthracycline: 300 mg/meters squared doxorubicin or equivalent. Relapse greater than one year after trastuzumab adjuvantly; two years following adjuvant anthracycline therapy (without trastuzumab).
- One prior chemotherapy for metastatic breast cancer allowed (may include trastuzumab for HER2+ patients), but no prior Doxil, adriamycin or epirubicin for metastatic breast cancer.
- At least 18 years of age.
- ECOG Performance Status of 0, 1, or 2.
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- Adequate organ function including the following:
- Adequate bone marrow reserve.
- Cardiac: Left ventricular ejection fraction (LVEF) greater than or equal to 55% by MUGA.
- Negative serum pregnancy test at the time of enrollment for women of child-bearing potential.
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
Who cannot join
- Pregnant or nursing women.
- Concurrent anticancer therapy.
- Participation in any investigational drug study within 28 days prior to study entry.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, uncontrolled hypertension, coronary artery disease, congestive heart failure, severe arrhythmia) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
- Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for greater than or equal to 2 weeks and off corticosteroids for greater than or equal to 1 week.
- History of interstitial lung disease or pulmonary fibrosis.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Albany, New York, 12208
Study site
Amsterdam, New York, 12010
Study site
Asheville, North Carolina, 28803
Study site
Burnsville, Minnesota, 55337
Study site
Columbia, Missouri, 65201
Study site
Dallas, Texas, 75230-2510
Study site
Dallas, Texas, 75231-4400
Study site
Dallas, Texas, 75246
Study site
Edina, Minnesota, 55435-2150
Study site
El Paso, Texas, 79902
Study site
El Paso, Texas, 79915
Study site
Houston, Texas, 77024
Study site
Hudson, New York, 12534
Study site
Latham, New York, 12110-0610
Study site
Maplewood, Minnesota, 55109
Study site
Midland, Texas, 79701-5946
Study site
Minneapolis, Minnesota, 55404
Study site
New Milford, Connecticut, 06776
Study site
Odessa, Texas, 79761
Study site
Plano, Texas, 75075-7787
Study site
Rexford, New York, 12148
Study site
Saint Paul, Minnesota, 55102-2389
Study site
Schenectady, New York, 12308
Study site
Sharon, Connecticut, 06069
Study site
Torrington, Connecticut, 06790
Study site
Troy, New York, 12180
Study site
Tyler, Texas, 75702
Study site
Woodbury, Minnesota, 55125
About this study
Official title: A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer
The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Amrubicin
- Keywords
- metastatic breast cancer, amrubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmrubicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac toxicity
Secondary outcomes (5)
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Duration of overall response
Time to tumor progression
Progression free survival
Toxicity profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study completionDec 2007
Why it stopped: Study Never Initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard S Ungerleider, MD, Study director, Theradex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380835
- Sponsor's protocol ID
- CNF3140-MBC-001
- Status last verified
- Sep 2008
- First submitted
- 26 Sep 2006
- Last updated
- 23 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00380835
- Acronym / sponsor ID
- CNF3140-MBC-001
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, amrubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Never Initiated
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study completion
- Dec 2007
- First posted
- 27 Sep 2006 (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 the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological or cytological diagnosis of breast cancer.
- Metastatic or recurrent disease, either HER2+ (FISH+ or 3+ IHC) or HER2-.
- Maximal dose of prior adjuvant anthracycline: 300 mg/meters squared doxorubicin or equivalent. Relapse greater than one year after trastuzumab adjuvantly; two years following adjuvant anthracycline therapy (without trastuzumab).
- One prior chemotherapy for metastatic breast cancer allowed (may include trastuzumab for HER2+ patients), but no prior Doxil, adriamycin or epirubicin for metastatic breast cancer.
- At least 18 years of age.
Key exclusion criteria (6 listed)
- Pregnant or nursing women.
- Concurrent anticancer therapy.
- Participation in any investigational drug study within 28 days prior to study entry.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, uncontrolled hypertension, coronary artery disease, congestive heart failure, severe arrhythmia) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
- Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for greater than or equal to 2 weeks and off corticosteroids for greater than or equal to 1 week.
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 |
|---|---|---|
| Amrubicin | Drug | – |
Primary outcome
Incidence of cardiac toxicity
5 secondary outcomes
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Duration of overall response
Time to tumor progression
Progression free survival
Toxicity profile
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2008.
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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.
Richard S Ungerleider, MD study director
Theradex
28 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 Amrubicin in people with Metastatic Breast Cancer, run by Celgene Corporation at 28 sites in United States.
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 11 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Incidence of cardiac toxicity. 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 23 Sep 2008.