Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Summary: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
  PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.

Detailed description: OBJECTIVES:
  -  Determine whether a change in epidermal growth factor receptor (EGFR) phosphorylation is detected in tumors of patients with locally advanced or metastatic breast cancer treated with erlotinib.
  -  Determine whether a change in other parameters of signal transduction that are downstream of EGFR (ERK and AKT) is detected in tumors of patients treated with this drug.
  -  Determine the toxicity of this drug in these patients.
  -  Determine the response duration and time to progression in patients treated with this drug.
  -  Correlate EGFR phosphorylation level with clinical findings and time to progression in patients treated with this drug.
  -  Correlate the pharmacokinetics of this drug with a change in EGFR phosphorylation in tumor biopsies of these patients.
  OUTLINE: Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
  Patients are followed within 4 weeks.
  PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 7-10 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the breast
  -  Locally advanced or metastatic disease
  -  Incurable disease
  -  Tumor accessible for biopsy
  -  Prior breast cancer allowed
  -  No symptomatic or untreated brain metastases or carcinomatous meningitis
  -  Neurologically stable patients with inactive brain metastases are allowed if off corticosteroids for at least 4 weeks prior to study
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Sex:
  -  Male or female
  Menopausal status:
  -  Not specified
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 3 months
  Hematopoietic:
  -  Granulocyte count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin normal
  -  ALT/AST no greater than 2.5 times upper limit of normal
  Renal:
  -  Creatinine normal OR
  -  Creatinine clearance at least 60 mL/min
  Cardiovascular:
  -  LVEF at least 40%
  -  No symptomatic congestive heart failure
  -  No unstable angina pectoris
  -  No cardiac arrhythmia
  Ophthalmic:
  -  No prior abnormalities of the cornea, including:
  -  Dry eye syndrome or Sjogren's syndrome
  -  Congenital abnormality (e.g., Fuch's dystrophy)
  -  Abnormal slit-lamp examination with a vital dye (e.g., fluorescein or Bengal-Rose)
  -  Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
  -  No concurrent use of contact lenses
  Other:
  -  No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (e.g., gefitinib or other anilinoquinazolines)
  -  No other concurrent uncontrolled illness
  -  No active infection
  -  No uncontrolled diabetes mellitus
  -  No psychiatric illness or social situation that would preclude study
  -  No untreated life-threatening disease
  -  No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  -  Weight less than 136 kg
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  See Disease Characteristics
  -  At least 2 weeks since prior hormonal therapy
  -  No concurrent hormonal therapy
  Radiotherapy:
  -  At least 3 weeks since prior radiotherapy
  -  No concurrent radiotherapy except localized external beam radiotherapy for palliative treatment of metastatic disease (cannot include significant cardiac muscle within the radiotherapy field)
  Surgery:
  -  Not specified
  Other:
  -  No other concurrent investigational anticancer agents

Relevance to patient case: not relevant