Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Albumin-Bound Paclitaxel; Cetuximab; Paclitaxel

Criteria

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