An open label, pharmacodynamic Study of (Z)-endoxifen in Patients withInvasive Breast Cancer Prior to Undergoing Mastectomy or Lumpectomy.

Phase 1

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12618001561279
• Lead Sponsor: Atossa Genetics AUS Pty Ltd, Australian entity of Atossa Therapeutics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-18
• Study Completion: 2022-12-30
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

1.Females 18 years of age or older;
2. Histologically confirmed invasive breast cancer (stage 1 or 2, ER+ low- grade [grade 1 or 2]);
3. Pathological invasive breast cancer diagnosis requiring mastectomy or lumpectomy;
4. Newly diagnosed, tamoxifen naïve;
5. Scheduled to undergo mastectomy or lumpectomy for invasive breast cancer at no less
than 15 days from commencement of treatment with the study drug;
6. Estrogen Receptor positive biopsy, as determined from a biopsy specimen obtained no
more than 3 months prior to entry (>=1% of the cells by IHC);
7. HER2 negative (as determined by IHC and/or FISH from a biopsy specimen obtained no more than 3 months prior to entry;
8. Eastern Cooperative Oncology Group (ECOG) score 0-1, an estimated life expectancy of
at least 12 months;
9. Adequate organ function
10. Women with child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
11. Provide consent for the collection of biopsy material;
12. Able to comprehend and sign the informed consent.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified