Clinical trial NCT00353717: Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma
Official title: Phase II of Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Neoplasms
Keywords: breast
basal like
carcinoma
metastatic
EGFR
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-07-19
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: tumor markers tumor size by ct
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Oncology Department Hadassah Ein Kerem POB 12000
Study officials:
affiliation: Hadassah Ein Kerem Jerusalem
name: Hovav Nechushtan, MD/PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Ein Kerem
name: Tamar Peretz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1158/1078-0432.CCR-04-0220.