Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery

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