Human Clinical Trials

Our research collaborations have resulted in clinical trials:

  • PIONEER: A window of opportunity trial (randomised phase II) funded by the Cambridge University Hospitals NHS Foundation Trust, to assess whether progesterone (using the repurposed drug megestrol acetate, i.e. Megace) increases the anti-cancer effect of the standard hormone treatment (letrozole) in addition to standard hormonal treatment in early stage, operable ER+ breast cancer. (Jason Carroll, PI. NCT03306472).
  • WinPro: A study funded by the Cancer Council of NSW, to investigate whether adding the drug Prometrium (progesterone) to endocrine therapy (aromatase inhibitor) before breast surgery will have a greater growth inhibitory effect on early breast cancers compared to endocrine therapy alone. (Elgene Lim, PI. NCT03906669). 
  • PEARL: A window of opportunity study funded by Cancer Research UK, Cambridge Institute, to test the combination of progesterone with Tamoxifen in premenopausal ER-positive, progesterone receptor-positive early breast cancer. (Carlo Palmieri, PI.  NCT02028507).
  • EMERALD: A window of opportunity study funded by Cancer Research UK, Cambridge Institute, to assess the biological effects of Enobosarm (a selective androgen receptor modulator; SARM) in ER-positive, treatment naïve breast cancer. (Carlo Palmieri, PI. NCT02463032).
  • ENOBOSARM: An international Phase II randomised trial funded by GTx Inc to test the efficacy and safety of enobosarm, a selective androgen receptor agonist, to target AR in women with advanced ER+/AR+ breast cancer. (Carlo Palmieri, PI. NCT01616758). Trial protocol and statistical analysis plan attached.
  • ARTEST: A Phase III randomised international clinical trial funded by VERU Inc, USA, to demonstrate the efficacy of enobosarm monotherapy in the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer as measured by radiographic progression free survival. (NCT04869943). 
  • ART2: A Phase II study of testosterone replacement in women experiencing aromatase inhibitor (Arimidex) side effects in adjuvant therapy for breast cancer. (Stephen Birrell, PI. NCT00497458).
  • Breast density study: A study to stratify screening processes based on risk factors that incorporate mammographic breast density as a new era for breast cancer screening and prevention. (Stephen Birrell, PI).

From the laboratory to the clinic