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Thursday, 07/29/2021 1:30:40 AM

Thursday, July 29, 2021 1:30:40 AM

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AG-1001-AU-02: AN OPEN LABEL, PILOT AND EXPANSION PHARMACODYNAMIC STUDY OF (Z)-ENDOXIFEN IN PATIENTS WITH INVASIVE BREAST CANCER PRIOR TO UNDERGOING MASTECTOMY OR LUMPECTOMY.
This study is designed to determine if Oral Endoxifen “turns’ down” or reduces tumor cell activity in patients with newly diagnosed estrogen receptor positive breast cancer. Participating patients will receive Oral Endoxifen for at least 21 days prior to surgery, or during the “Window of Opportunity.” Tissue samples obtained from the initial biopsy and again at surgery will be analyzed and results compared to determine if cancer cell activity is lower following Oral Endoxifen administration. If a reduction in tumor cell activity is reduced in at least two of the first eight patients, then the study will be expanded to enroll an additional 17 patients.

This study is being conducted by Dr. Vinod Ganju, Peninsula & South Eastern Haematology & Oncology Group, Franksten, Victoria, Australia.



Interim Results: The open-label study was designed to permit an interim analysis of the Ki-67 change. The requirement was to achieve a meaningful Ki-67 change in at least two of eight patients. Interim results are as follows: All patients (N=6) experienced a significant reduction in Ki-67. A summary of these results includes:

--Ki-67 was reduced by more than 50% in every patient in the window of opportunity between initial biopsy and surgery, with an overall reduction of 74%.
--All six patients had a Ki-67 below 25% after treatment. In a paper entitled, “Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients,” Ki-67 was an independent prognostic value for predicting overall survival in ER+ breast cancer patients. Ki-67 levels below 25% were associated with the lowest risk of death in this systematic review and meta-analysis.
--Treatment ranged from 16-40 days with an average of 22 days.
--There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats, which are often a tolerability challenge for patients on tamoxifen.



https://atossatherapeutics.com/clinical-trials/





The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number

ACTRN12618001561279
Ethics application status

Approved
Date submitted

11/09/2018
Date registered

18/09/2018
Date last updated

9/10/2018
Type of registration

Prospectively registered


https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375802


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