Clinical trial NCT00238290 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: trastuzumab + letrozole
SMILES: N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed breast cancer

               -  Advanced disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside
             previously irradiated areas that is ≥ 20 mm OR ≥ 10 mm if the slice thickness of the
             CT scan or MRI is ≤ 5 mm

               -  No nonmeasurable lesions as the only site of measurable disease, including any of
                  the following:

                    -  Osteoblastic bone metastases

                    -  Ascites

                    -  Pleural or pericardial effusions

                    -  Carcinomatous lymphangitis of the lung

          -  Progressive disease after prior treatment with a nonsteroidal aromatase inhibitor
             (e.g., letrozole or anastrozole) in an adjuvant or advanced disease setting

          -  HER-2 amplification ≥ 2 by fluorescence in situ hybridization

          -  No clinical symptoms or history of CNS or leptomeningeal metastases (no imaging is
             required)

          -  No visceral involvement with risk for organ dysfunction

          -  Hormone receptor status:

               -  Estrogen receptor- and/or progesterone receptor-positive tumor

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Postmenopausal, defined by 1 of the following:

               -  At least 55 years of age

               -  Less than 55 years of age with spontaneous cessation of menses for ≥ 1 year

               -  Less than 55 years of age with spontaneous cessation of menses within the past
                  year, but amenorrheic with biochemical evidence of postmenopausal status

               -  Underwent prior bilateral oophorectomy

               -  Radiation or chemically induced menopause (treatment with luteinizing
                  hormone-releasing hormone antagonists must continue during study treatment)

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  AST and ALT ≤ 2 times upper limit of normal

        Renal

          -  Creatinine clearance > 30 mL/min

        Cardiovascular

          -  No uncontrolled cardiac disease, including any of the following:

               -  Unstable angina

               -  Arrhythmia

               -  Hypertension

          -  No history of congestive heart failure

          -  No myocardial infarction within the past 6 months

          -  LVEF > 50% by echocardiogram

        Pulmonary

          -  No severe dyspnea at rest

        Other

          -  No other malignancy within the past 5 years except adequately treated carcinoma in
             situ of the cervix or localized nonmelanoma skin cancer

          -  No psychiatric disability that would preclude study participation or giving informed
             consent

          -  No active autoimmune disease

          -  No uncontrolled diabetes

          -  No other serious underlying medical condition that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior trastuzumab (Herceptin®)

        Chemotherapy

          -  Prior neoadjuvant or adjuvant chemotherapy allowed

          -  No prior palliative chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  Not specified

        Other

          -  More than 1 month since prior experimental drugs on another clinical trial

          -  No concurrent drugs that contraindicate study treatment

          -  No other concurrent anticancer drugs

          -  No other concurrent investigational drugs