Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: erlotinib hydrochloride; TUNEL assay; protein expression analysis; immunohistochemistry staining method; laboratory biomarker analysis; liquid chromatography; mass spectrometry; matrix-assisted laser desorption ionization mass spectrometry; therapeutic conventional surgery
Intervention description: Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.; Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens; Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens; Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens; Used to assess level of expression of genetic markers in pre-therapy and surgical specimens; Used to determine blood plasma levels of Erlotinib on the day of surgery; Used to determine blood plasma levels of Erlotinib on the day of surgery; After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue; Surgical treatment will occur within 24-hours following completion of therapy.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

          -  No serious medical illness that, in the judgement of the treating physician, places
             the patient at high risk of operative mortality

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy for this primary breast cancer

          -  At least 7 days since prior tamoxifen or raloxifene as a preventive agent