ATOSSA: This trial is testing hormone therapy, using oral (Z)-Endoxifen, as a treatment for patients with invasive breast cancerAn open label, pilot and expansion pharmacodynamic Study of (Z)-endoxifen in Patients with Invasive Breast Cancer Prior to Undergoing Mastectomy or Lumpectomy

Exclusion

1. Diagnosis of inflammatory breast carcinoma;
2. Stage IV breast cancer;
3. Diagnosis of HER2 positive disease;
4. Palpable nodes or clinical suspicion of axillary node positivity;
5. Concurrent treatment with another anti-estrogen;
6. Presence of an infection including ulcerations and fungal infections in the breast to be studied;
7. Coagulopathies, bleeding diatheses, thrombocytopenia or current anticoagulant use;
8. Several hepatic impairments, defined as Child-Pugh Class C or worse;
9. Prior radiation to the breast or chest wall;
10. Known severe hypersensitivity to any drugs in this study;
11. Pregnant or lactating;
12. Impaired renal function;
13. Impaired cardiac function or history of cardiac problems;
14. Poor nutritional state (as determined by clinician);
15. Depressed bone marrow;
16. Presence of serious infection;
17. Presence of ascites (as determined by clinician);
18. Presence of pleural effusion;
19. Hepatic disease, positive serology (for hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] antibodies) or known active disease due to hepatitis B virus, hepatitis C virus, auto-immune liver disease or sclerosing cholangitis;
20. Positive serology for human immunodeficiency virus (HIV) or known active disease due to HIV infection;
21. Major operation, obvious trauma within 28 days before randomization;
22. Concurrent participation in an experimental drug study;
23. Any reasons for which the investigator considers the volunteer is not suitable for the study.
24. Concurrent chemotherapy.
25. History of previous thromboembolic events.