Breast Cancer
Conditions
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer
Brief 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, tolerability and human anti-human antibodies (HAHA) response | — |
| Tissue markers | — |
| Measure of tumor glucose levels | — |
| Pathological response | — |
| Tumor size by MRI | — |