Clinical trial NCT00075764 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: anastrozole, fulvestrant
SMILES: CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N, [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer meeting 1 of the following criteria:

               -  Metastatic disease (M1)

               -  Multiple sites of new disease that is clinically obvious metastatic disease
                  (e.g., multiple sites of new osseous disease)

          -  Measurable or nonmeasurable disease

          -  No known brain or CNS metastases

          -  Hormone receptor status:

               -  Estrogen-receptor positive* AND/OR

               -  Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of
                  > 10 fmol/mg cytosol protein by ligand binding assay or positive by
                  immunohistochemistry

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Sex

          -  Female

        Menopausal status

          -  Postmenopausal, as defined by 1 of the following:

               -  Prior bilateral oophorectomy

               -  More than 12 months since last menstrual period with no prior hysterectomy

               -  At least 55 years of age with prior hysterectomy

               -  Under 55 years of age with a prior hysterectomy without oophorectomy and with
                  estradiol and follicle-stimulating hormone levels consistent with menopause

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor
             deficiency)

        Hepatic

          -  INR ≤ 1.6

        Renal

          -  Not specified

        Other

          -  HIV negative

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer currently in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy for recurrent or metastatic disease

        Chemotherapy

          -  No prior chemotherapy for recurrent or metastatic disease

          -  More than 12 months since prior adjuvant or neoadjuvant chemotherapy

          -  No concurrent chemotherapy for malignancy

        Endocrine therapy

          -  Prior adjuvant hormonal therapy allowed

          -  At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH)
             analogues

               -  Menstrual periods must not have resumed since LHRH therapy

          -  More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g.,
             anastrozole, letrozole, or exemestane)

          -  More than 12 months since prior fulvestrant

          -  No prior hormonal therapy for recurrent or metastatic disease

          -  No other concurrent hormonal therapy for malignancy

          -  No concurrent hormone replacement therapy

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  No long-term anticoagulant therapy (except antiplatelet therapy)