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Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Primary Purpose

Breast Neoplasms

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

cetuximab paclitaxel

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring breast, basal like, carcinoma, metastatic, EGFR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Oncology Department Hadassah Ein Kerem POB 12000Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

tumor markers tumor size by ct

Secondary Outcome Measures

Full Information

NCT ID

NCT00353717

First Posted

July 18, 2006

Last Updated

January 12, 2009

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00353717

Brief Title

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

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

Keywords

breast, basal like, carcinoma, metastatic, EGFR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

cetuximab paclitaxel

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

tumor markers tumor size by ct

Time Frame

two years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hovav Nechushtan, MD/PhD

Phone

972-0508946057

hovavnech@hadassah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Tamar Peretz, MD

Phone

972-2 6777825

tamiy@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hovav Nechushtan, MD/PHD

Organizational Affiliation

Hadassah Ein Kerem Jerusalem

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tamar Peretz, MD

Organizational Affiliation

Hadassah Ein Kerem

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology Department Hadassah Ein Kerem POB 12000

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamar Peretz, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15328174

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.

Results Reference

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Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

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