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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor markers tumor size by ct

Outcome Time Frame:

two years

Principal Investigator

Hovav Nechushtan, MD/PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Ein Kerem Jerusalem


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

November 2006

Completion Date:

September 2009

Related Keywords:

  • Breast Neoplasms
  • breast
  • basal like
  • carcinoma
  • metastatic
  • EGFR
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma