CAN1012 in OED, DCIS, and LCIS.

Exclusion Criteria

• •1. Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.
• •2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.
• •3. Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.
• •4. History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism/hyperthyroidism are not exclusionary.
• •5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).
• •6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.
• •7. Has a known history of Human Immunodeficiency Virus (HIV). Testing is not required unless mandated by local health authority.
• •8. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known history of Hepatitis C virus (defined as HCV RNA) infection. Testing for Hepatitis B and Hepatitis C is not required unless mandated by local health authority.
• •9. Has a baseline electrocardiogram (ECG) with a prolonged QTc interval \> 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.
• •10. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.