Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

cetuximab paclitaxel

Intervention Type DRUG

weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2

Interventions

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cetuximab paclitaxel

weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2

Intervention Type DRUG

Other Intervention Names

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weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No