Clinical trial NCT00101062 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: celecoxib, letrozole
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Reason stopped: 
    study drug unavailable
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the breast

               -  Locally advanced or metastatic disease

          -  Measurable disease

               -  No bone disease only

          -  No history of brain metastases unless controlled with radiotherapy or surgical
             resection for ≥ 6 months before study entry

          -  Hormone receptor status:

               -  Estrogen receptor- OR progesterone receptor-positive

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Postmenopausal, as defined by 1 of the following:

               -  Prior bilateral oophorectomy

               -  Prior bilateral ovarian irradiation

               -  No spontaneous menstrual bleeding within the past 12 months

               -  Age 55 and over AND prior hysterectomy without oophorectomy

               -  Age 54 and under AND prior hysterectomy without oophorectomy (or status of
                  ovaries is unknown) AND documented follicle-stimulating hormone level in
                  postmenopausal range

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 3 months

        Hematopoietic

          -  Granulocyte count ≥ 1,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Other

          -  No prior allergic reaction attributed to compounds of similar chemical or biologic
             composition to study drugs

          -  No prior allergic reaction to sulfonamides

          -  No active peptic ulcer disease

          -  No active infection

          -  No other medical condition that would preclude study participation

          -  Able to swallow oral medication

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for metastatic or recurrent disease

        Endocrine therapy

          -  No prior endocrine therapy for metastatic disease

               -  Prior adjuvant tamoxifen allowed

          -  No prior aromatase inhibitors

          -  No prior hormonal therapy for recurrent disease

          -  No other concurrent hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  See Menopausal status

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

          -  See Menopausal status

        Other

          -  No concurrent fluconazole or lithium

          -  No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other
             cyclooxygenase-2 inhibitors

               -  Concurrent chronic cardioprotective low-dose aspirin allowed

          -  No other concurrent investigational agents