Clinical trial NCT00674414 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: everolimus
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    idmc decision due to accrual issue (82 pts accrued / 120 expected)
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of invasive breast cancer

               -  Previously untreated disease

          -  Candidate for breast-conserving surgery, as defined by both of the following:

               -  Clinical stage cT1-3, cN0-2 disease

               -  Clinical stage M0 disease (bone scan, chest X-ray, and liver ultrasound required
                  at screening to exclude metastatic disease)

          -  HER2-positive primary tumor, defined as meeting either of the following criteria:

               -  IHC 3+

               -  IHC 2+ and FISH positive (centralized confirmation)

          -  No inflammatory breast cancer or bilateral breast cancer

               -  Patients who have been treated for cancer of the contralateral breast can be
                  included if there is at least a 5 year time interval from last systemic treatment
                  for breast cancer before randomization into this study

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-1

          -  Menopausal status not specified

          -  WBC ≥ 3.5 x 10^9/L

          -  ANC ≥ 1.5 x 10^9/L

          -  Platelet count ≥ 100 x 10^9/L

          -  Hb ≥ 10 g/dL

          -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Serum transaminases activity ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

          -  FEV > 55% by MUGA or ECHO

          -  Spirometry and DLCO > 50% of normal

          -  O_2 saturation > 88% at rest on room air

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known hypersensitivity to everolimus, sirolimus, trastuzumab (Herceptin®), or
             lactulose

          -  No hypercholesterolemia/hypertriglyceridemia ≥ grade 3

               -  No hypercholesterolemia/hypertriglyceridemia ≥ grade 2 with history of coronary
                  artery disease (despite lipid-lowering treatment if given)

          -  No uncontrolled infection

          -  No other concurrent severe and/or uncontrolled medical disease which could compromise
             participation in the study, including any of the following:

               -  Uncontrolled hypertension

               -  Congestive cardiac failure

               -  Ventricular arrhythmias

               -  Active ischemic heart disease

               -  Myocardial infarction within the past year

               -  Chronic liver or renal disease

               -  Active gastrointestinal tract ulceration

               -  Severely impaired lung function

          -  No known history of HIV seropositivity

          -  No psychological, familial, sociological, or geographical condition potentially
             hampering compliance with the study protocol and follow-up schedule

          -  Willing to participate in the biological investigations

          -  Not deprived of liberty or placed under guardianship

          -  Patients must be affiliated to a Social Security System

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 30 days (from the screening visit) since prior other investigational drugs

          -  More than 5 days (from randomization) since prior and no concurrent strong inhibitors
             or inducers of the isoenzyme CYP3A, including any of the following

               -  Rifabutin

               -  Rifampicin

               -  Clarithromycin

               -  Ketoconazole

               -  Itraconazole

               -  Voriconazole

               -  Ritonavir

               -  Telithromycin

          -  No other concurrent anti-cancer treatments such as chemotherapy,
             immunotherapy/biological response modifiers, endocrine therapy, or radiotherapy