- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353717
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
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.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Hovav Nechushtan, MD/PhD
- Phone Number: 972-0508946057
- Email: hovavnech@hadassah.org.il
Study Contact Backup
- Name: Tamar Peretz, MD
- Phone Number: 972-2 6777825
- Email: tamiy@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Recruiting
- Oncology Department Hadassah Ein Kerem POB 12000
-
Principal Investigator:
- Tamar Peretz, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tumor markers tumor size by ct
Time Frame: two years
|
two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hovav Nechushtan, MD/PHD, Hadassah Ein Kerem Jerusalem
- Principal Investigator: Tamar Peretz, MD, Hadassah Ein Kerem
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Breast Neoplasms
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Paclitaxel
- Albumin-Bound Paclitaxel
- Cetuximab
Other Study ID Numbers
- cpblb1-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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