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

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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


- To evaluate the change in total tumor choline levels in women with operable early
breast cancer in response to neoadjuvant CP-751871 treatment.


- 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

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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy

Safety Issue:


Principal Investigator

Douglas Yee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • Breast Neoplasms