Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery

Summary: RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
  PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.

Detailed description: Primary
  -  To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.
  Secondary
  -  To assess changes in tumor glucose levels after CP-751871 treatment using magnetic resonance spectroscopy in these patients.
  -  To assess the safety, tolerability, and immunogenicity of CP-751871 in these patients.
  -  To assess the effect of CP-751871 on Insulin-like Growth Factor 1 receptor (IGF-1R) signaling markers in tumor tissues in these patients.
  -  To assess the clinical efficacy of CP-751871 in these patients (MRI and pathological responses).
  OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway.
  After completion of study treatment, patients will be followed for 5 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed early operable adenocarcinoma of the breast
  -  No evidence of invasive lobular breast disease
  -  Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI
  -  Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy
  -  Must have available or scheduled core breast biopsy procedure
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  ECOG performance status 0-1
  -  Platelet count ≥ 100,000/mm^³
  -  Neutrophil count ≥ 1,500/mm³
  -  Creatinine < 1.5 times upper limit of normal (ULN)
  -  Bilirubin < 1.5 times ULN
  -  ALT and AST < 2.5 times ULN
  -  Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
  -  Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
  -  No known hypersensitivity to monoclonal antibodies
  -  No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
  -  No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
  -  No significant active cardiac disease including any of the following:
  -  Uncontrolled high blood pressure (i.e., systolic blood pressure [BP] > 160 mm Hg and diastolic BP > 95 mm Hg)
  -  Unstable angina
  -  Deep venous thrombosis
  -  Pulmonary embolism
  -  Cerebrovascular attack
  -  Valvular disease
  -  Congestive heart failure
  -  Myocardial infarction with the past 6 months
  -  Serious cardiac arrhythmias
  -  No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements
  PRIOR CONCURRENT THERAPY:
  -  More than 4 weeks since prior surgery and recovered
  -  More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
  -  No prior anti-IGF-1R based investigational therapy
  -  No prior systemic therapy for primary disease
  -  No concurrent chronic systemic high-dose immunosuppressive steroid therapy
  -  Low-dose steroids for nausea and vomiting control allowed
  -  Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed
  -  No concurrent other anticancer drugs or therapy

Relevance to patient case: not relevant