Breast NeoplasmPhase 2NCT00687440
A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)
A Phase 2 study testing Pegylated Liposomal Doxorubicin, Docetaxel and Trastuzumab in people with Breast Neoplasm, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Pegylated Liposomal Doxorubicin, Docetaxel and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2005to 24 Oct 2008
- Phase
- Phase 2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must fulfill all the following criteria:
- Females aged 18 to 70 years-old.
- Willingness to participate in the study and comply with its procedures.
- Documented diagnosis of metastatic breast carcinoma (stage IV) Human Epidermal Growth Factor Receptor 2 (HER2) overexpressing (Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization(FISH) +).
- No prior chemotherapy for metastatic breast cancer.
- Adjuvant or neo-adjuvant chemotherapy is allowed according to the following rules:
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- patients treated with anthracyclines if all the following conditions are met:
- Doxorubicin total dose <= 300 mg/m^2
- Epirubicin total dose <= 480 mg/m^2
- Chemotherapy-free interval of > 12 months
- no taxane-based adjuvant or neo-adjuvant chemotherapy is allowed;
- patients treated with non-anthracycline/taxane adjuvant or neo-adjuvant chemotherapy regimens are freely eligible (i.e. cyclophosphamide/methotrexate/fluorouracil (CMF) or similar regimens).
- At least one measurable lesion according to RECIST criteria.
- Complete hematologic and biologic baseline evaluation within 2 weeks prior to start of treatment.
- Complete Tumor baseline evaluation including a total body computed tomography (CT) scan within 4 weeks prior to start of treatment.
- Left ventricular ejection fraction (LVEF) >= 50% as determined by echocardiogram or Multi Gated Acquisition (MUGA) scan.
- World Health Organization (WHO) performance status 0,1.
- Life expectancy > 3 months.
- Laboratory requirements :
- Hematology :
- Neutrophils > 1.5 x 10^9/L
- Platelets > 100 x 10^9/L
- Hemoglobin > 10 g/dL
- Hepatic function:
- Total bilirubin <= 1.25 x the upper-normal limits (UNL);
- ASAT (Aspartate Aminotransferase or SGOT), ALAT (Alanine aminotransferase or SGPT) <= 2.5 x the upper-normal limits;
- For patients with liver metastases:
- Total bilirubin < 1.5 x the UNL (Upper limit of normal) ;
- ASAT and/or ALAT < 3 x the UNL;
- Renal function :
- Serum Creatinine < 1.5 x the UNL.
- Women of child bearing potential must have a negative serum pregnancy test and be using adequate contraception.
- Patients must be accessible for treatment and follow-up.
Who cannot join
- Patients will not be enrolled if any of the following criteria apply:
- Prior chemotherapy for metastatic disease.
- History of prior malignancy in the last 10 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).
- Radiation to disease areas within 3 weeks of study initiation.
- Symptomatic peripheral neuropathy > grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria.
- Other serious illness or medical condition.
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- LVEF < 50% as determined by echocardiogram or MUGA scan.
- Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Active infection.
- Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Concurrent treatment with corticosteroids used for reasons other than for premedication. However patients receiving chronic treatment with corticosteroids (> 6 months) at low dose (< 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible.
- Taxane-based adjuvant or neo-adjuvant chemotherapy < 12 months.
- Other concurrent chemotherapy, immunotherapy, radiotherapy or any other investigational medication, for the treatment of the tumor.
- Pregnant or breast-feeding women.
About this study
Official title: Pegylated Liposomal Doxorubicin (Caelyx) in Combination With Herceptin and Taxotere as First-line Chemotherapy in Metastatic Breast Cancer Patients: A 2 Stage Phase II, Open Label, Multicenter Study.
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.
- Conditions
- Breast Neoplasm
- Being tested
- Pegylated Liposomal Doxorubicin, Docetaxel, Trastuzumab
- 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 Caelyx
Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m^2 on day 1, every 3 weeks
Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks.
DocetaxelDrug
Also called Taxotere
Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks.
TrastuzumabDrug
Stage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Caelyx, Docetaxel, Trastuzumab | Experimental | Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab. Receives: Drug: Pegylated Liposomal Doxorubicin; Drug: Docetaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.
Measured: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study start15 Jul 2005
- Primary completion24 Oct 2008
- Study completion24 Oct 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687440
- Sponsor's protocol ID
- P03679
- Other IDs
- Eudract No. 2004-003989-15
- Status last verified
- Jun 2018
- First submitted
- 27 May 2008
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Liposomal Doxorubicin (Caelyx) in Combination With Herceptin and Taxotere as First-line Chemotherapy in Metastatic Breast Cancer Patients: A 2 Stage Phase II, Open Label, Multicenter Study.
- ClinicalTrials.gov ID
- NCT00687440
- Acronym / sponsor ID
- P03679
- Conditions
- Breast Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services
- Study start
- 15 Jul 2005 (actual)
- Primary completion
- 24 Oct 2008 (actual)
- Study completion
- 24 Oct 2008 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 15 Feb 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, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caelyx, Docetaxel, Trastuzumab | Experimental | Drug: Pegylated Liposomal Doxorubicin, Drug: Docetaxel, Drug: TrastuzumabStage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx. Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Females aged 18 to 70 years-old.
- Willingness to participate in the study and comply with its procedures.
- Documented diagnosis of metastatic breast carcinoma (stage IV) Human Epidermal Growth Factor Receptor 2 (HER2) overexpressing (Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization(FISH) +).
- No prior chemotherapy for metastatic breast cancer.
- Adjuvant or neo-adjuvant chemotherapy is allowed according to the following rules:
Key exclusion criteria (16 listed)
- Prior chemotherapy for metastatic disease.
- History of prior malignancy in the last 10 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).
- Radiation to disease areas within 3 weeks of study initiation.
- Symptomatic peripheral neuropathy > grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria.
- Other serious illness or medical condition.
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: CaelyxStage 1: 25 subjects will be treated with Caelyx IV 30 mg/m^2 on day 1, every 3 weeks Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks. | Drug | Caelyx, Docetaxel, Trastuzumab |
| DocetaxelAlso: TaxotereStage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks. | Drug | Caelyx, Docetaxel, Trastuzumab |
| TrastuzumabStage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks). | Drug | Caelyx, Docetaxel, Trastuzumab |
Primary outcome
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 Liposomal Doxorubicin, Docetaxel and Trastuzumab 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 33 inclusion and 16 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 3 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 15 Feb 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?
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria (time frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.). 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 3 Jul 2018.