Breast NeoplasmsPhase 2NCT00050427
A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
A Phase 2 study testing ET743 in people with Breast Neoplasms and Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasms, Neoplasms by Site
- What is being tested?
- ET743
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Dec 2006
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced breast cancer
- Prior therapy with anthracycline and taxane (2 types of chemotherapy drugs)
- At least one measureable tumor lesion
- Adequate bone marrow, hepatic and renal function
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Who cannot join
- Known hypersensitivity to any components of the i.v. formulation of ET-743 or dexamethasone
- Pregnant or lactating women
- Known metastases (spread) of cancer to the central nervous system
- History of another neoplastic disease unless in remission for five years or more.
About this study
Official title: A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.
Read the detailed description
Patients will be enrolled in the study after all study specific-entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300 mcg/m2 once every 21 days (Treatment B) will be given to patients as a 3-hour intravenous (i.v). infusion via a central venous catheter which is a tube placed into a large vein that is used to administer medications. All patients will be given dexamethasone 10 mg i.v. 30 minutes before each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.
- Conditions
- Breast Neoplasms, Neoplasms, Neoplasms by Site, Breast Diseases, Skin Diseases
- Being tested
- ET743
- Keywords
- Trabectedin, Yondelis, ET743, Advanced breast cancer, Breast, Cancer, Antineoplastic Agents, Alkylating Agents, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Breast Neoplasms, Neoplasms, Neoplasms by Site, Breast Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET743Drug
580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
ET743Drug
1,300 mcg/m2, 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | ET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion. Receives: Drug: ET743 |
| 002 | Experimental | ET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion. Receives: Drug: ET743 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with objective response in each treatment arm.
Measured: Up to approximately 52 weeks
Secondary outcomes (5)
Progression-free survival (PFS)
Measured: Up to approximately 52 weeks
Time to progression (TTP)
Measured: Up to approximately 52 weeks
Overall survival (OS)
Measured: Up to approximately 52 weeks
The number of patients with treatment-emergent adverse events
Measured: Up to approximately 52 weeks
Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin
Measured: During the first two 28-day treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2002 (estimated)
- Study startDec 2002
- Study completionDec 2006
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 NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050427
- Sponsor's protocol ID
- CR004525
- Other IDs
- ET743-INT-3
- Status last verified
- Apr 2011
- First submitted
- 9 Dec 2002
- Last updated
- 28 Apr 2011
- Results posted
- No
Publications
Goldstein LJ, Gurtler J, Del Prete SA, Tjulandin S, Semiglazov VF, Bayever E, Michiels B. Trabectedin as a single-agent treatment of advanced breast cancer after anthracycline and taxane treatment: a multicenter, randomized, phase II study comparing 2 administration regimens. Clin Breast Cancer. 2014 Dec;14(6):396-404. doi: 10.1016/j.clbc.2014.06.006. Epub 2014 Aug 15.
PubMed 25239225
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00050427
- Acronym / sponsor ID
- CR004525
- Conditions
- Breast Neoplasms, Neoplasms, Neoplasms by Site, Breast Diseases, Skin Diseases
- Keywords
- Trabectedin, Yondelis, ET743, Advanced breast cancer, Breast, Cancer, Antineoplastic Agents, Alkylating Agents, Molecular Mechanisms of Pharmacological Action
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Study start
- Dec 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Dec 2002 (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 this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.
Detailed description
Patients will be enrolled in the study after all study specific-entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300 mcg/m2 once every 21 days (Treatment B) will be given to patients as a 3-hour intravenous (i.v). infusion via a central venous catheter which is a tube placed into a large vein that is used to administer medications. All patients will be given dexamethasone 10 mg i.v. 30 minutes before each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: ET743ET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion. |
| 002 | Experimental | Drug: ET743ET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of advanced breast cancer
- Prior therapy with anthracycline and taxane (2 types of chemotherapy drugs)
- At least one measureable tumor lesion
- Adequate bone marrow, hepatic and renal function
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Key exclusion criteria (4 listed)
- Known hypersensitivity to any components of the i.v. formulation of ET-743 or dexamethasone
- Pregnant or lactating women
- Known metastases (spread) of cancer to the central nervous system
- History of another neoplastic disease unless in remission for five years or more.
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 |
|---|---|---|
| ET743580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion. | Drug | 001 |
| ET7431,300 mcg/m2, 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion. | Drug | 002 |
Primary outcome
Number of patients with objective response in each treatment arm.
Time frame: Up to approximately 52 weeks
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 52 weeks
Time to progression (TTP)
Time frame: Up to approximately 52 weeks
Overall survival (OS)
Time frame: Up to approximately 52 weeks
The number of patients with treatment-emergent adverse events
Time frame: Up to approximately 52 weeks
Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin
Time frame: During the first two 28-day treatment cycles
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 28 Apr 2011.
- Derived from this study: PubMed 25239225Goldstein LJ, Gurtler J, Del Prete SA, Tjulandin S, Semiglazov VF, Bayever E, Michiels B. Trabectedin as a single-agent treatment of advanced breast cancer after anthracycline and taxane treatment: a multicenter, randomized, phase II study comparing 2 administration regimens. Clin Breast Cancer. 2014 Dec;14(6):396-404. doi: 10.1016/j.clbc.2014.06.006. Epub 2014 Aug 15.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ET743 in people with Breast Neoplasms and Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 4 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 28 Apr 2011. 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?
Number of patients with objective response in each treatment arm. (time frame: Up to approximately 52 weeks). 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 NCT00050427, 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 28 Apr 2011.