A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Breast Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Neoplasms

Treatments: Drug: ET743

Study type: Interventional

Funder types: Industry

Identifiers

NCT00050427

CR004525

ET743-INT-3

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

001

Experimental group

Description:

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.

Treatment:

Drug: ET743

Drug: ET743

002

Experimental group

Description:

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.

Treatment:

Drug: ET743

Drug: ET743