Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00353717
• Other study ID #: cpblb1-HMO-CTIL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 18, 2006
• Last updated: January 12, 2009
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: Hovav Nechushtan, MD/PhD
• Phone: 972-0508946057
• Email: hovavnech[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• cetuximab paclitaxel
weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2

Locations

Country	Name	City	State
Israel	Oncology Department Hadassah Ein Kerem POB 12000	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Nielsen TO, Hsu FD, Jensen K, Cheang M, Karaca G, Hu Z, Hernandez-Boussard T, Livasy C, Cowan D, Dressler L, Akslen LA, Ragaz J, Gown AM, Gilks CB, van de Rijn M, Perou CM. Immunohistochemical and clinical characterization of the basal-like subtype of invasive breast carcinoma. Clin Cancer Res. 2004 Aug 15;10(16):5367-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor markers tumor size by ct		two years