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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: figitumumab
* Other: imaging biomarker analysis
* Other: laboratory biomarker analysis
* Other: pharmacological study
* Procedure: conventional surgery
* Procedure: magnetic resonance spectroscopic imaging
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: figitumumab|nan|
|Other: imaging biomarker analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Other: pharmacological study|nan|
|Procedure: conventional surgery|nan|
|Procedure: magnetic resonance spectroscopic imaging|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and human anti-human antibodies (HAHA) response |  |  | 
| Tissue markers |  |  | 
| Measure of tumor glucose levels |  |  | 
| Pathological response |  |  | 
| Tumor size by MRI |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA breast cancer, stage IB breast cancer, stage II breast cancer