A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
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ClinicalTrials.gov Identifier: NCT00050427 |
Recruitment Status :
Completed
First Posted : December 18, 2002
Last Update Posted : April 28, 2011
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Condition or disease | Intervention/treatment | Phase |
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Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases | Drug: ET743 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer |
Study Start Date : | December 2002 |
Actual Study Completion Date : | December 2006 |

Arm | Intervention/treatment |
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Experimental: 001
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.
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Drug: 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. |
Experimental: 002
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.
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Drug: 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. |
- Number of patients with objective response in each treatment arm. [ Time Frame: Up to approximately 52 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050427
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00050427 |
Obsolete Identifiers: | NCT01328327 |
Other Study ID Numbers: |
CR004525 ET743-INT-3 |
First Posted: | December 18, 2002 Key Record Dates |
Last Update Posted: | April 28, 2011 |
Last Verified: | April 2011 |
Trabectedin Yondelis ET743 Advanced breast cancer |
Breast Cancer Antineoplastic Agents, Alkylating Agents Molecular Mechanisms of Pharmacological Action |
Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Breast Diseases |
Trabectedin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |