Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
In this trial, patients will be given 4mg/day of oral (Z)-Endoxifen, for a minimum of 21 days until the day before surgery (inclusive).
Conditions
This trial is treating people with breast cancer
Eligibility
Inclusion
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
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.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Atossa Genetics, Inc.
Scientific Title
An open label, pilot and expansion pharmacodynamic Study of (Z)-endoxifen in Patients with Invasive Breast Cancer Prior to Undergoing Mastectomy or Lumpectomy
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information