Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer

R-Pharm

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer; Triple Negative Locally Advanced Non-resectable Breast Cancer

Treatments: Drug: ixabepilone; Drug: ixabepilone + cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633464

CA163-139

Details and patient eligibility

About

The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast cancer

Enrollment: 79 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
• Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

Exclusion criteria

• Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+
• Neuropathy > Grade 1
• Prior systemic therapy for metastatic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Arm A (ixabepilone 40 mg^2)

Experimental group

Description:

ixabepilone 40 mg/m\^2 every 3 weeks

Treatment:

Drug: ixabepilone

Arm B (cetuximab 250 mg/m^2 + ixabepilone 40 mg/m^2)

Experimental group

Description:

cetuximab 400 mg/m\^2 loading dose then 250 mg/m\^2 weekly + ixabepilone 40 mg/m\^2 every 3 weeks

Treatment:

Drug: ixabepilone + cetuximab