Phase I Combination w/ Epirubicin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-02-28

Brief Summary

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Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

Participants received 25 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.

Epirubicin

Intervention Type DRUG

Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

Participants received 30 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.

Epirubicin

Intervention Type DRUG

Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

Participants received 35 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.

Epirubicin

Intervention Type DRUG

Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

Interventions

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Ixabepilone

Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.

Intervention Type DRUG

Epirubicin

Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

Intervention Type DRUG

Other Intervention Names

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IXEMPRA® BMS-247550 Epothilone

Eligibility Criteria

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Inclusion Criteria

* Women ≥18 years
* Histologically or cytologically confirmed diagnosis of metastatic breast cancer
* Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)