Clinical trial NCT00499681 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: lapatinib ditosylate, letrozole
SMILES: CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1, N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion Criteria:

          -  Clinical stage I, II, or III operable invasive mammary carcinoma, confirmed by
             histological analysis

               -  Measurable residual tumor at the primary site

                    -  Measurable disease is defined as any mass that can be reproducibly measured
                       by physical examination, mammogram, and/or ultrasound and can be accurately
                       measured in at least one dimension (longest diameter to be recorded) as 10
                       mm (1 cm)

          -  Available core biopsies from the time of diagnosis

               -  May include sections of paraffin-embedded material

          -  Scheduled to undergo surgical treatment with either segmental resection or total
             mastectomy

          -  Prior history of contralateral breast cancer allowed if patient has no evidence of
             recurrence of their initial primary breast cancer within the last 5 years

          -  HER2-positive by Herceptest (3+) or FISH

          -  ER-positive and/or PR-positive by IHC

        Exclusion Criteria:

          -  Locally recurrent breast cancer

          -  Evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)

        PATIENT CHARACTERISTICS:

        Inclusion Criteria:

          -  Female

          -  Postmenopausal, as defined by any of the following:

               -  At least 55 years of age

               -  Under 55 years of age and amenorrheic for at least 12 months OR
                  follicle-stimulating hormone (FSH) values ≥ 40 IU/L and estradiol levels ≤ 20
                  IU/L

               -  Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at
                  least 6 months

          -  ECOG performance status 0-1

          -  ANC ≥ 1,000/mm³

          -  Platelet count ≥ 100,000/mm³

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

          -  Bilirubin ≤ 1.5 times ULN

          -  AST and ALT ≤ 1.5 times ULN

          -  Able to swallow and retain oral medication

          -  Cardiac ejection fraction normal by echocardiogram (or MUGA scan if an echocardiogram
             cannot be performed or is inconclusive)

        Exclusion Criteria:

          -  Premenopausal breast cancer, pregnant, or lactating

          -  Serious medical illness, that in the judgment of the treating physician, places the
             patient at high risk of operative mortality

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel

          -  Ulcerative colitis

          -  History of other malignancy

               -  Patients who have been disease-free for 5 years, or patients with a history of
                  completely resected non-melanoma skin cancer or successfully treated in situ
                  carcinomas are eligible

          -  Active or uncontrolled infection

          -  Dementia, altered mental status, or any psychiatric condition that would prohibit the
             understanding or rendering of informed consent

          -  Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart
             failure

        PRIOR CONCURRENT THERAPY:

        Exclusion Criteria:

          -  Prior chemotherapy for primary breast cancer

          -  Tamoxifen or raloxifene as a preventive agent within the past 21 days

          -  Hormone replacement therapy (e.g., conjugated estrogens tablets [Premarin]) within the
             past month

          -  Prior therapy with anthracyclines

          -  Investigational drug within the past 30 days or 5 half-lives, whichever is longer

          -  Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery,
             immunotherapy, hormonal therapy, or any other biologic therapy) other than letrozole

          -  Concurrent treatment with an investigational agent