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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Trastuzumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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