Breast NeoplasmPhase 4NCT00779285
Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)
A Phase 4 study testing Pegylated Liposomal Doxorubicin in people with Breast Neoplasm, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Pegylated Liposomal Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Aug 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
- Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m^2 and <360mg/m^2 doxorubicin or >430mg/m^2 and <650mg/m^2 epirubicin).
- Women >18 years of age.
- Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (computed tomography (CT) scan and/or magnetic resonance imaging (MRI)).
- Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks.
- Left ventricular ejection fraction >50%.
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- Normal organ function, except if abnormal due to tumor involvement.
- Adequate bone marrow function as indicated:
- Platelets >100,000/mm^3
- Hemoglobin >9 g/dL
- Neutrophils >1,500/mm^3
- Adequate renal function as indicated by:
- Serum Creatinine <1.5 x the upper limit of normal
- Adequate liver function, as indicated by:
- Bilirubin and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2 times upper limit of normal (<4 times upper limit of normal when related to primary disease)
- Subjects must be capable to demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed intrauterine device (IUD), condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- Subjects must understand and be able to adhere to the dosing and visit schedules.
Who cannot join
- Patient is pregnant or is breastfeeding.
- Patients with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing Cremophor® EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate).
- Prior chemotherapy for metastatic disease.
- Clinically significant hepatic disease (except liver metastases of primary disease).
- Uncontrolled bacterial, viral, or fungal infection.
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- Radiotherapy in the last 4 weeks or prior radiation therapy to more than one-third of the hemopoietic sites.
- Any other currently known malignancy or pre-malignant lesions or any history of other malignancy within the past five years (except non-melanoma skin cancer and surgically cured cervical cancer).
- Symptomatic brain metastasis.
- Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
- Documented human immunodeficiency virus (HIV) infection.
- Any condition (medical, social, psychological) which would prevent adequate follow-up.
About this study
Official title: Cardiac Safety Profile of Caelyx Therapy in Anthracyclin Pretreated Metastatic Breast Cancer Patients.
The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.
- Conditions
- Breast Neoplasm
- Being tested
- Pegylated Liposomal Doxorubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal DoxorubicinDrug
Also called SCH 200746
Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles Receives: Drug: Pegylated Liposomal Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Events
A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).
Measured: Every 4 weeks during 6 cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startFeb 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779285
- Sponsor's protocol ID
- P04057
- Other IDs
- EUDRACT NO. 2004-001177-25
- Status last verified
- Jun 2015
- First submitted
- 23 Oct 2008
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Safety Profile of Caelyx Therapy in Anthracyclin Pretreated Metastatic Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT00779285
- Acronym / sponsor ID
- P04057
- Conditions
- Breast Neoplasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 10 Mar 2010
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 evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Drug: Pegylated Liposomal DoxorubicinPegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
- Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m^2 and <360mg/m^2 doxorubicin or >430mg/m^2 and <650mg/m^2 epirubicin).
- Women >18 years of age.
- Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (computed tomography (CT) scan and/or magnetic resonance imaging (MRI)).
- Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks.
Key exclusion criteria (13 listed)
- Patient is pregnant or is breastfeeding.
- Patients with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing Cremophor® EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate).
- Prior chemotherapy for metastatic disease.
- Clinically significant hepatic disease (except liver metastases of primary disease).
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 |
|---|---|---|
| Pegylated Liposomal DoxorubicinAlso: SCH 200746Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator. | Drug | Single-arm |
Primary outcome
Cardiac Events
Time frame: Every 4 weeks during 6 cycles.
A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated Liposomal Doxorubicin in people with Breast Neoplasm, run by Merck Sharp & Dohme LLC.
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 18 inclusion and 13 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 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiac Events (time frame: Every 4 weeks during 6 cycles.). 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 14 Jul 2015.