Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Phase 1

• Conditions: Breast Neoplasms
• Interventions: Drug: cetuximab paclitaxel

• Registration Number: NCT00353717
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-19
• Study Start: 2006-11
• Last Update Submitted: 2009-01-12
• Last Update Posted: 2009-01-13
• Status Verified: 2009-02
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cetuximab paclitaxel	-

Primary Outcome Measures

Name	Time	Method
tumor markers tumor size by ct	two years

Trial Locations

Locations (1)

Oncology Department Hadassah Ein Kerem POB 12000; 🇮🇱 Jerusalem, Israel