Clinical trial NCT00051051 (phase 2, status: completed)
Conditions: breast neoplasms
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: ci-1033
SMILES: FC1=C(Cl)C=C(NC2=NC=NC3=CC(OCCCN4CCOCC4)=C(NC(=O)C=C)C=C23)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Female, at least 18 years of age

          -  Histologically confirmed diagnosis of breast cancer

          -  Metastatic (Stage IV) disease

          -  Progressive or recurrent disease following the most recent therapy

          -  No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease

          -  At least one measurable target lesion as defined by Response Evaluation Criteria in
             Solid Tumors (RECIST) that has not been irradiated

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, determined
             within 2 weeks prior to randomization

          -  Estimated life expectancy of > 12 weeks

          -  Capable of giving written informed consent

          -  Capable of swallowing intact CI-1033 capsules

          -  Capable of understanding and adhering to the protocol requirements

          -  No prior exposure to CI-1033 or other agents that target the erbB receptor family
             (such as Herceptin, Iressa, Tarceva, IMC-C225, and EKB-569)

          -  No known hypersensitivity reaction to tyrosine kinase inhibitors

          -  Adequate liver, renal, or bone marrow function determined within 2 weeks prior to
             randomization

          -  No cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6
             weeks for nitrosoureas or mitomycin)

          -  No immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior
             to baseline disease assessments

          -  No hormone therapy (including hormone replacement therapy) within 4 weeks prior to
             baseline disease assessments (6 weeks for megestrol acetate)

          -  Patients must have recovered from the acute effects of any radiation therapy or
             surgery

          -  No treatment with any other investigational therapy within 4 weeks prior to baseline
             disease assessments

          -  No history of any cancer other than the present condition (except nonmelanoma skin
             cancer or carcinoma in situ of the cervix) within the last 5 years

          -  No patients with untreated brain metastases or patients that have not recovered from
             treatment for brain metastases

          -  No known malabsorption syndrome or other condition that may impair absorption of study
             medication

          -  No comorbidity or condition which compromises compliance with this protocol as judged
             by the investigator or that would significantly complicate interpretation of the
             safety profile of CI-1033

          -  No patients having reproductive potential who are not using a method of birth control
             or who are pregnant or breastfeeding or have a positive pregnancy test during baseline

        Exclusion Criteria:

        Prior exposure to CI-1033 or other agents that target the erbB receptor family; cytotoxic
        chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas
        or mitomycin); immunotherapy (including Herceptin) or other biologic therapy within 2 weeks
        prior to baseline disease assessments; hormone therapy (including hormone replacement
        therapy) within 4 weeks prior to baseline disease assessments; 6 weeks for megestrol
        acetate (to exclude the possibility of a hormone-withdrawal response); patients with
        untreated brain metastases.