Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353717

Enrollment

Registered

2006-07-19

Start date

2006-11-30

Completion date

2009-09-30

Last updated

2009-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

breast, basal like, carcinoma, metastatic, EGFR

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.

Interventions

DRUGcetuximab paclitaxel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
tumor markers tumor size by ct	two years

Countries

Israel

Contacts

Primary ContactHovav Nechushtan, MD/PhD

hovavnech@hadassah.org.il972-0508946057

Backup ContactTamar Peretz, MD

tamiy@hadassah.org.il972-2 6777825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026