Clinical trial NCT00559507 (phase 2, status: completed)
Conditions: estrogen receptor-negative breast cancer, male breast cancer, progesterone receptor-negative breast cancer, recurrent breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.621, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: saracatinib
SMILES: CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed carcinoma of the breast

               -  Unresectable disease

               -  Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage
                  IV) disease

          -  Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as
             < 10% expression by immunohistochemistry (IHC)

          -  Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors
             [RECIST]) as ≥ 1 unidimensionally measurable lesion ≥ 20mm by conventional techniques
             or ≥ 10 mm by spiral computed tomography (CT) scan

               -  Measurable target lesions must not be in a previously irradiated field

          -  Patients with locally advanced, unresectable disease must have progression of disease
             following no more than one first-line chemotherapy regimen

          -  Patients with evidence of recurrent disease during or within 6 months after adjuvant
             chemotherapy will be considered to have failed one line of chemotherapy for metastatic
             disease

          -  Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as
             immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH)
             amplification > 2.1, must have received trastuzumab (Herceptin®) in either the
             adjuvant or metastatic setting and have had recurrence or progression of disease,
             respectively

          -  No known brain metastases

          -  Male and female patients eligible

          -  Menopausal status not specified

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 (Karnofsky PS
             60-100%)

          -  Life expectancy > 3 months

          -  Absolute neutrophil count ≥ 1,500/mcL

          -  Platelet count ≥ 100,000/mcL

          -  Hemoglobin > 9 g/dL

          -  Total bilirubin normal

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤
             2.5 x institutional upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Urine protein creatinine (UPC) ratio must be ≤ 1.0

               -  Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to
                  be eligible for study

          -  Not pregnant or nursing

          -  Women of child-bearing potential and men must use adequate contraception (e.g.,
             hormonal or barrier method of birth control or abstinence) prior to, during, and for 8
             weeks after completion of study therapy

          -  Able to understand and willing to sign a written informed consent document

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to AZD0530

          -  No QTc interval ≥ 500 msecs

          -  No condition that impairs the ability to swallow AZD0530 tablets, including the
             following:

               -  Gastrointestinal tract disease resulting in an inability to take oral medication
                  or a requirement for IV alimentation

               -  Prior surgical procedures affecting absorption

               -  Active peptic ulcer disease

          -  No intercurrent cardiac dysfunction including, but not limited to, any of the
             following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Uncontrolled cardiac arrhythmia

               -  History of myocardial infarction within 6 months of treatment

          -  No uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  No severe restrictive or obstructive lung disease according to baseline pulmonary
             function studies including any of the following pulmonary function test (PFT)
             parameters:

               -  Total lung capacity < 60%

               -  Forced vital capacity < 50%

               -  Forced expiratory volume in one second (FEV_1) < 50%

               -  Diffusion capacity of carbon monoxide (DLCO) < 50%

               -  Resting room air O_2 saturation < 92% or a decline in O_2 saturation > 4% with
                  exercise

          -  Patients with metastatic disease may have received no more than 1 prior chemotherapy
             regimen

          -  No unresolved toxicity ≥ grade 3 from agents received more than 3 weeks earlier

          -  No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering study

          -  No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry

          -  More than 7 days since prior and no concurrent use of specifically prohibited
             cytochrome P 450 3A4 (CYP3A4) agents

          -  No concurrent megestrol acetate, even when prescribed for appetite stimulation

          -  No other concurrent investigational or commercial agents for the treatment of breast
             cancer

          -  No concurrent combination antiretroviral therapy for human immunodeficiency virus
             (HIV)-positive patients

          -  No concurrent megestrol acetate