Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

Key facts

Study ID: NCT00033514
Run by: Jonsson Comprehensive Cancer Center
People needed: 27
Starts: 2001-08-01
Expected to finish: 2011-12-01
Last updated by the study team: 2020-10-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women aged > 18 years
Histologically documents metastatic breast cancer
HER2 positive using Fluorescence In Situ Hybridization (FISH)
For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.
For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
A life expectancy of > 3 months
Use of effective means of contraception

You may not qualify if…

For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.

Where it is running

Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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