Clinical trial NCT00217659 (phase 2, status: withdrawn)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: anastrozole, goserelin acetate
SMILES: CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed breast cancer

               -  Recurrent or metastatic (stage IV) disease

                    -  Patients with a local regional recurrence, including axillary and/or chest
                       wall involvement, are eligible

          -  Measurable or non-measurable disease

          -  Brain metastases allowed provided they have been treated with surgery or radiotherapy
             AND have remained stable for ≥ 3 months

          -  Hormone receptor status:

               -  Estrogen receptor- OR progesterone receptor- positive disease by standard
                  immunohistochemical techniques

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Male

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  No evidence of severe or uncontrolled hepatic disease

        Renal

          -  No evidence of severe or uncontrolled renal disease

        Cardiovascular

          -  No evidence of severe or uncontrolled cardiac disease

        Pulmonary

          -  No evidence of severe or uncontrolled respiratory disease

        Other

          -  Fertile patients must use effective barrier-method contraception during and for 12
             weeks after the completion of study treatment

          -  No known HIV positivity

          -  Able to receive oral medication

               -  Patients with a gastrointestinal tube are eligible

          -  No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH
             agonist analogues, or any components of the study drugs

          -  No active infection requiring systemic therapy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer

          -  No evidence of other severe or uncontrolled systemic disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors

        Chemotherapy

          -  At least 14 days since prior chemotherapy for this cancer and recovered

          -  No more than 1 prior chemotherapy regimen for metastatic disease

          -  No concurrent chemotherapy

        Endocrine therapy

          -  At least 14 days since prior hormonal therapy for this cancer and recovered

          -  Prior tamoxifen allowed

          -  No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or
             fulvestrant

          -  No other concurrent hormonal therapy (e.g., estrogen-based therapies)

        Radiotherapy

          -  See Disease Characteristics

          -  At least 14 days since prior radiotherapy for this cancer and recovered

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics