Epi-PRIMED Metastatic Breast Cancer Trial


Our novel Phase 1B clinical trial for patients with metastatic breast cancer, particularly those with the triple negative (TNBC) subtype, is now closed for recruitment.

The Study is entitled “Phase Ib Safety and Pharmacokinetics (PK)/ Pharmacodynamics (PD) Study to Determine the Dosage of Abraxane in Combination with Phenelzine Sulfate in Metastatic or Inoperable Locally Advanced Breast Cancer

Participates in this multi-centre clinical study were offered a new combination therapy, comprising the standard of care chemotherapeutic drug Abraxane®  (scientific name: nanoparticle albumin-bound paclitaxel) with a second PBS listed drug Nardil® (scientific name: phenelzine sulfate).  Nardil is an antipsychotic drug, which is also known to inhibit LSD1.   This new combination is designed to test the hypothesis that metastatic disease can be effectively treated with the addition of an LSD1 inhibitor to Abraxane®.

This novel and “first of its kind” epigenetic program is based on the research work of Professor Sudha Rao at the University of Canberra.  We believe that inhibiting LSD1 reverts the mesenchymal phenotype of circulating tumour cells (CTC) and cancer stem cells (CSC) back to the epithelial state, enabling chemotherapy to remove the previously resistant cell types.  This is made possible by blocking LSD1’s role in the epigenetic reprograming of those cells.  In addition to this benefit, we also believe that both innate and adaptive immune responses are being re-invigorated by inhibiting LSD1 and that the inhibitory checkpoint blockage is being removed.  Collectively, we believe that this provides clearance of the CTC and CSC burden and, in doing so, will prolong remission.

The study was being conducted at the following three clinical trial centres:

  1. The Canberra Region Cancer Centre, with the site investigators Professor Desmond Yip and Dr Laeeq Malik;
  2. Southern Medical Day Care Centre, with the site investigator Professor Phil Clingan; and
  3. The Liverpool Cancer Therapy Centre, with the site investigator Dr Eugene Moylan.

The Principal Coordinating Investigators for the study are Professor Desmond Yip and Dr Laeeq Malik, who are based at the Canberra Region Cancer Centre, which is located at The Canberra Hospital, Garran, ACT.

A total of 13 females with confirmed metastatic disease including TNBC will be considered eligible for the trial if they satisfy the following general criteria:

  1. Patients who are ≥18 years;
  2. Fluent in written & spoken English & able to provide written informed consent to participate;
  3. Patient who are able to attend a 12-week study treatment regimen & end of study visit;
  4. Metastatic Breast Cancer (MBC) or inoperable locally advanced breast cancer diagnosis, either TNBC or not;
  5. No cytotoxic therapy in the previous 3 weeks;
  6. Patients with child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin or β-hCG) & have agreed to practice an effective, reliable contraceptive regimen for the duration of the trial;
  7. ECOG Performance Status 0 or 1; &
  8. Adequate liver function, as evidenced by bilirubin of <1.5 times upper limit of normal (ULN) & ALT/AST <2 times of ULN. However, AST & ALT of <5 times ULN, if liver metastases are present, is acceptable.

Further details are available at www.ANZCTR.org.au/ACTRN12617000943347.aspx

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Professor Sudha Rao