None listed
Conditions
Brief summary
The purpose of this study is to examine the action of a new medication (called “(Z)-endoxifen”) in patients with breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or older and are scheduled to undergo mastectomy or lumpectomy for invasive breast cancer Study details All participants in this study will take oral capsules of the study medication for at least 14 days and up to 30 days prior to day of their surgery. Before and after treatment, participants will provide a tumour biopsy and blood sample. Additionally, participants will need to consent to their removed tissue being tested. It is hoped this research will provide information regarding the action of (Z)-endoxifen and potentially lead to new therapeutics for breast cancer.
Interventions
- the dose administered, (Z)-Endoxifen 4 mg/day
- the duration of administration, a minimum of 21 days until the day before surgery, inclusive
- the mode of administration, oral capsules
A study diary will be provided to each participant for the purpose of recording study drug
administration (date and time) and adverse events.
A safety follow up phone call will be conducted on Days 7, 14, 21 and weekly thereafter until the visit before surgery. For each phone call the following will be performed
- the dose administered, (Z)-Endoxifen 4 mg/day - the duration of administration, a minimum of 21 days until the day before surgery, inclusive - the mode of administration, oral capsules A study diary will be provided to each participant for the purpose of recording study drug administration (date and time) and adverse events. A safety follow up phone call will be conducted on Days 7, 14, 21 and weekly thereafter until the visit before surgery. For each phone call the following will be performed: - Document telephone contact day and time; - Instruct the participant to volunteer any information regarding AEs that she may have experienced by asking an open question (e.g., “How do you feel?”). Patient engagement in this study will be for a minimum of 43 days. This includes up to 28 days of screening period, treatment for at least 14-days and for no more than 30 days until the day before their scheduled surgery.
Sponsors
Atossa Genetics AUS Pty Ltd, Australian entity of Atossa Therapeutics Inc
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed