Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

Exclusion Criteria

• •Active hepatitis B or hepatitis C with abnormal liver function tests.
• •HIV positive patients receiving antivirals.
• •Inflammatory/inoperable breast cancer.
• •HER2-positive as determined using ASCO-CAP Guidelines.
• •Oncotype Dx Breast Recurrence Score® result on diagnostic breast tissue greater than or equal to 26.
• •Prior endocrine therapy for breast cancer.
• •Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ).
• •Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as:
• •* Active infection or chronic infection requiring chronic suppressive antibiotics;
• •* Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function;
• •* Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids);
• •* Seizure disorders requiring medication.
• •Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry.
• •Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy).
• •Definitive clinical or radiologic evidence of metastatic disease.
• •History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with radiotherapy or contralateral invasive breast cancer at any time.
• •Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
• •Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes. Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months) of myocardial infarction, or symptomatic arrhythmia at the time of randomization.
• •* Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Such patients are comfortable at rest. Less than ordinary physical activity that causes fatigue, palpitation, dyspnea, or anginal pain.
• •* Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest.
• •The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.