Phase I Combination w/ Epirubicin

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Metastatic Breast Cancer

Treatments: Drug: Ixabepilone; Drug: Epirubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322374

CA163-104

Eudract No: 2005-004864-22

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• Number of prior chemotherapy lines of treatment in the metastatic setting ≥2

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Epirubicin

Drug: Ixabepilone

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

Experimental group

Description:

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.

Treatment:

Drug: Epirubicin

Drug: Ixabepilone

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

Experimental group

Description:

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.

Treatment:

Drug: Epirubicin

Drug: Ixabepilone