Breast NeoplasmPhase 2NCT00779129
A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)
A Phase 2 study testing Pegylated Lyposomal Doxorubicin and Cyclophosphamide in people with Breast Neoplasm, run by Merck Sharp & Dohme LLC.
Trial summary
Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Pegylated Lyposomal Doxorubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Aug 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged >=18 years.
- Subject must have histologic diagnosis of breast carcinoma.
- Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging.
- Subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy.
- Subject must have ECOG performance status 0, 1, or 2.
- Subject must have life expectancy > 6 months
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- Subject must have left ventricular ejection fraction >=55% as determined by MUGA scan.
- Subject must have normal organ function, except if abnormal due to tumor involvement:
- Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=90 g/L, Neutrophils >=1.5 X 10^9/L)
- Adequate renal function (serum creatinine < 2 X the upper limit of normal (ULN)
- Adequate liver function (bilirubin < 2 times ULN, AST or ALT < 2 times ULN in the absence of liver metastasis, AST or ALT < 5 times ULN in the presence of liver metastasis.
- Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
- Subject must be able to understand and give informed consent.
Who cannot join
- Age > 75 years old.
- Subject who is pregnant or breastfeeding or is unwilling to use adequate contraception.
- Subject who has had a previous chemotherapy for metastatic disease.
- Subject who has history of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure.
- Subject who has clinically significant hepatic disease in regard to Hepatitis B, Hepatitis C, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer.
- Subject who has uncontrolled bacterial, viral, or fungal infection.
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- Subject who exhibits confusion or disorientation.
- Subject with any condition which would prevent adequate follow-up.
- Subject who has received radiotherapy in the last 4 weeks.
- Subject with any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Subject who has brain metastasis.
- Subject who is not able to give informed consent.
About this study
Official title: Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer
Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.
- Conditions
- Breast Neoplasm
- Being tested
- Pegylated Lyposomal Doxorubicin, Cyclophosphamide
- 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 Lyposomal DoxorubicinDrug
Also called SCH 200746
Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
CyclophosphamideDrug
Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2 Receives: Drug: Pegylated Lyposomal Doxorubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to response; Duration of response; Time to progression; Survival
Measured: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival.
Secondary outcomes (1)
Left ventricular ejection fraction (LVEF), (MUGA Scan); Radiological imaging; Examination of adverse events, laboratory data, vital signs
Measured: LVEF following cycles 2, 4, 5, and 6 of study drug; Radiological imaging every 6 weeks.
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 startMar 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779129
- Sponsor's protocol ID
- P02948
- Status last verified
- Sep 2015
- First submitted
- 23 Oct 2008
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Trudeau ME, Clemons MJ, Provencher L, Panasci L, Yelle L, Rayson D, Latreille J, Vandenberg T, Goel R, Zibdawi L, Rahim Y, Pouliot JF. Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines. J Clin Oncol. 2009 Dec 10;27(35):5906-10. doi: 10.1200/JCO.2009.22.7504. Epub 2009 Oct 26.
PubMed 19858391
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00779129
- Acronym / sponsor ID
- P02948
- Conditions
- Breast Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Mar 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 24 Oct 2008 (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.
Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.
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 Lyposomal Doxorubicin, Drug: CyclophosphamideCaelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female, aged >=18 years.
- Subject must have histologic diagnosis of breast carcinoma.
- Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging.
- Subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy.
- Subject must have ECOG performance status 0, 1, or 2.
Key exclusion criteria (12 listed)
- Age > 75 years old.
- Subject who is pregnant or breastfeeding or is unwilling to use adequate contraception.
- Subject who has had a previous chemotherapy for metastatic disease.
- Subject who has history of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure.
- Subject who has clinically significant hepatic disease in regard to Hepatitis B, Hepatitis C, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer.
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 Lyposomal DoxorubicinAlso: SCH 200746Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. | Drug | Single Arm |
| CyclophosphamideCyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. | Drug | Single Arm |
Primary outcome
Time to response; Duration of response; Time to progression; Survival
Time frame: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival.
1 secondary outcome
Left ventricular ejection fraction (LVEF), (MUGA Scan); Radiological imaging; Examination of adverse events, laboratory data, vital signs
Time frame: LVEF following cycles 2, 4, 5, and 6 of study drug; Radiological imaging every 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Results publication: PubMed 19858391Trudeau ME, Clemons MJ, Provencher L, Panasci L, Yelle L, Rayson D, Latreille J, Vandenberg T, Goel R, Zibdawi L, Rahim Y, Pouliot JF. Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines. J Clin Oncol. 2009 Dec 10;27(35):5906-10. doi: 10.1200/JCO.2009.22.7504. Epub 2009 Oct 26.
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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 2 study testing Pegylated Lyposomal Doxorubicin and Cyclophosphamide 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 13 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: finished, as of the sponsor's last update on 30 Sep 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to response; Duration of response; Time to progression; Survival (time frame: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00779129, which also lists 1 linked publication.
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 30 Sep 2015.