Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score

Inclusion Criteria

• •Patients must have a histologically confirmed diagnosis of hormone receptor positive, HER2 negative invasive breast carcinoma.
• •Tumors must be estrogen and/or progesterone receptor positive according to ASCO/CAP 2010 guidelines as either ER or PR ≥ 1% positive nuclear staining by immunohistochemistry. Estrogen and/or progesterone receptor results by Oncotype Dx will not be accepted.
• •Tumors must be HER2 negative as defined according to ASCO/CAP 2013, as HER2 0 - 1+ by IHC or non-amplified FISH or CISH. If HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (must be a ratio of \< 2), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standards.
• •Patients must not have had prior ipsilateral breast-conserving surgery or total mastectomy and be eligible for neoadjuvant treatment.
• •Clinical Stage II-IIIC (T2-4 N0-3 M0) by mammogram, ultrasound or MRI
• •Baseline Oncotpye Dx recurrence score \< 25.
• •Staging studies with a CT scan of the chest and abdomen and bone scan, or a PET/CT is required for clinical stage III, and are considered optional for stage II breast cancers.
• •Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed:
• •* Multifocal disease is defined as more than one invasive cancer \< 2 cm from the largest lesion within the same breast quadrant.
• •* Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants.
• •* Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each other.
• •* In patients with multicentric or bilateral invasive breast cancers, all sampled lesions must be hormone receptor-positive and HER2-negative. Any lesion measuring \> 1 cm must have an Oncotype Dx and the score must be \< 25. Lesions less than 1 cm in size are not required to have an Oncotype Dx. One lesion (typically the largest) should be designated as the target lesion for which clinical and radiographic response to the neoadjuvant therapy will be judged.
• •* Patients with a hormone receptor-positive, HER2-negative invasive cancer that meets study criteria may have ductal carcinoma in situ in another quadrant of the same breast or in the contralateral breast even if the DCIS is hormone receptor-negative.
• •Patients must have adequate bone marrow function, as defined by peripheral granulocyte count of ≥ 1,500/mL, hemoglobin ≥ 9 g/dL and a platelet count ≥ 100,000/ mL within 28 days prior to registration.
• •Patients must have adequate hepatic function obtained within 28 days prior to registration and documented by all of the following:
• •* Bilirubin ≤ 1.5 mg/dL (or ≤ 3.0 mg/dL if due to Gilbert's Syndrome)
• •* ALT and AST ≤ 1.5 x Institutional Upper Limit of Normal (IULN)
• •* Alkaline phosphatase ≤ 1.5 x IULN
• •Patients must have adequate renal function with serum creatinine level ≤ IULN within 28 days prior to registration.
• •Patients must have a fasting cholesterol ≤ 300 mg/dl OR ≤7.75 mmol/L and triglycerides ≤ 2.5 x IULN obtained within 28 days prior to registration. Patients may be on lipid lowering agents to reach these values.
• •Patients must have a ECOG performance status of 0-2.
• •Patients must be able to take oral medications.
• •Postmenopausal women (women are considered post-menopausal and not of child-bearing potential if they are \> 18 years of age and have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms or biochemically postmenopausal by estradiol and FSH levels) prior to enrollment, or have had surgical bilateral oophorectomy (with or without hysterectomy) prior to registration. Medical ovarian suppression with LHRH agonists to render a patient postmenopausal will not be acceptable.
• •16\. Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any screening procedures in accordance with institutional and federal guidelines.