cp-751871 in treating women with early-stage breast cancer that can be removed by surgery

Conditions: Breast Cancer

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.

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 criteria:
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

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer