NCT00353717

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 13, 2009

Status Verified

February 1, 2009

First QC Date

July 18, 2006

Last Update Submit

January 12, 2009

Conditions

Breast Neoplasms

Keywords

breastbasal likecarcinomametastaticEGFR

Outcome Measures

Primary Outcomes (1)

  • tumor markers tumor size by ct

    two years

Study Arms (1)

1

EXPERIMENTAL
Drug: cetuximab paclitaxel

Interventions

cetuximab paclitaxelDRUG

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

Also known as: weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic breast carcinoma of the basal like subtype with available biopsy for analysis and ECOG PS of 2 or less

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Department Hadassah Ein Kerem POB 12000

Jerusalem, 91120, Israel

RECRUITING

Related 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. doi: 10.1158/1078-0432.CCR-04-0220.

    PMID: 15328174BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsCarcinomaNeoplasm Metastasis

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hovav Nechushtan, MD/PHD

    Hadassah Ein Kerem Jerusalem

    PRINCIPAL INVESTIGATOR

  • Tamar Peretz, MD

    Hadassah Ein Kerem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hovav Nechushtan, MD/PhD

CONTACT

972-0508946057hovavnech@hadassah.org.il

Tamar Peretz, MD

CONTACT

972-2 6777825tamiy@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 19, 2006

Study Start

November 1, 2006

Study Completion

September 1, 2009

Last Updated

January 13, 2009

Record last verified: 2009-02

Locations

IL(1)