A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

R-Pharm

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: trastuzumab; Drug: ixabepilone; Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00490646

CA163-140

Eudract No: 2007-000721-21

Details and patient eligibility

About

The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.
• Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
• Measurable disease
• Left Ventricular Ejection Fraction (LVEF) ≥50%

Exclusion criteria

• Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)
• Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
• Neuropathy > Grade 1
• Significant cardiovascular disease
• Any brain metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm A

Experimental group

Description:

trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m\^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.

Treatment:

Drug: trastuzumab

Drug: ixabepilone

Arm B

Active Comparator group

Description:

trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m\^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.

Treatment:

Drug: trastuzumab

Drug: docetaxel