PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer

Exclusion Criteria

• •Concurrent enrollment on another investigational therapy
• •Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone \>50mg; hydrocortisone \>40mg, prednisone \>10mg, methylprednisone \>8mg or dexamethasone \>1.5mg; or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
• •EKG demonstrating QTC \> 480 ms
• •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• •* History or evidence of increased cardiovascular risk including any of the following: (i) current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation, (ii) History of acute coronary syndromes (including myocardial infarction and unstable angina, coronary angioplasty, or stenting within 6 months prior to enrollment, (iii) Current \>/= Class II congestive heart failure as defined by New York Heart Association
• •* History of pneumonitis/interstitial lung disease or severely impaired lung function with a previously documented spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
• •* Uncontrolled diabetes
• •* Active (acute or chronic) or uncontrolled severe infections
• •* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• •* A known history of HIV seropositivity as reported by the patient
• •* History of major surgical resection involving the stomach or small bowel, or pre-existing impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, Crohn's disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• •* Patients with an active, bleeding diathesis
• •* History of retinopathy or retinal vein occlusion
• •Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative urine or serum pregnancy test.
• •Patients who have received prior treatment with a CDK4/6 inhibitor
• •Patients with a known hypersensitivity to Hydroxychloroquine or any of its derivatives
• •Patients with prior hydroxychloroquine exposure for a duration of \> 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and/or Her2-directed therapy) for the index malignancy
• •Patients who have initiated bone modifying agents within 3 months prior to study enrollment
• •A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.