Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Study Overview
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Brief Summary
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Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR) negative breast cancer. It is notable for the high level of epidermal growth factor receptor (EGFR) expression in this tumor subtype . Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women. This is a small phase I/II study.

Detailed Description
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Basal like breast carcinoma is a Her2, ER PR negative breast cancer. It is notable for the high percentage of EGFR expression in this tumor subtype.Weekly taxol (paclitaxel) is widely used in breast cancer patients with metastatic disease. Erbitux (cetuximab) is a monoclonal antibody that shown its ability to enhance activity of chemotherapy in colon carcinoma. Thus we wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of women with basal like breast carcinoma. This is a small phase II study that will hopefully provide initial data as to the general tolerability and response rate of this combination in this disease. Furthermore, pathologic analysis will be used to try and assess relation of response with the presence of immunohistochemical markers such as EGFR expression.

Official Title
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Phase II of Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: cetuximab paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with metastatic breast carcinoma of the basal like subtype with available biopsy for analysis and ECOG PS of 2 or less Exclusion Criteria: Pregnancy BUN, blood creatinine, AST, ALT > X3 of upper limits of normal More than previous 2 chemotherapy lines in the metastatic settings or the use of previous inhibitors of EGFR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: cetuximab paclitaxel<br>* weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2<br>* Other names: weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor markers tumor size by ct |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast, basal like, carcinoma, metastatic, EGFR