Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.

Key facts

Study ID

NCT00633750

Run by

Vanderbilt-Ingram Cancer Center

People needed

50

Starts

2002-08-01

Expected to finish

2007-10-01

Last updated by the study team

2012-09-05

Who can join

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

You may qualify if…

• Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma
• Diagnosis may be made by fine needle aspiration cytology or core biopsy
• A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining

You may not qualify if…

• Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*
• Locally advanced disease includes any of the following:
• Primary tumor ≥ 5 cm (T3)
• Tumor of any size with direct extension to the chest wall or skin (T4a-c)
• Inflammatory breast cancer (T4d)
• Fixed axillary lymph node metastases (N2)
• Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors ≥ 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible
• Measurable residual tumor at the primary site
• Measurable disease is defined as any mass that can be reproducibly measured by physical examination
• Planning to undergo surgical treatment with either segmental resection or total mastectomy
• Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer
• No locally recurrent breast cancer
• No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• ANC ≥ 1,000/mm\^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 times ULN
• Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) ≤ 1.5 times ULN
• Must be at least 18 years old
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Meharry Medical College — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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