A Study to Assess the Ability of a Novel Endocrine Treatment for Breast Cancer, Irosustat, to Slow Down Cancer Growth (IPET)
This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether.
IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of scan can show how body tissues are working, as well as what they look like. FLT-PET scans will be performed before and following treatment with Irosustat. As cancer cells grow faster than the normal cells around them, they will take up more of the radioactive substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer will take up less of the tracer.
Blood samples will be taken at regular intervals to assess what the new drug does to the body and the safety and tolerability of Irosustat will be assessed. The study incorporates translation aspects/endpoints which are based on the collection of tumour biopsies before and after treatment with Irosustat although the later biopsy is not mandatory.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open Label, Preoperative Study to Assess the Efficacy of the Novel Steroid Sulfatase Inhibitor Irosustat in Postmenopausal Women With Early Oestrogen Receptor Positive Breast Cancer|
- Changes in FLT uptake as assessed by PET following 2 weeks of treatment with Irosustat [ Time Frame: Patients will have a baseline FLT-PET/CT scan and a follow-up scan after 2 weks of treatment with Irosustat ] [ Designated as safety issue: No ]
- To characterize the pharmacodynamic profile of Irosustat by measuring peripheral blood steroid hormone levels [ Time Frame: Blood samples will be drawn from patients on day 1, day 7, day 14 and 28 days post administration of the last dose of Irosustat ] [ Designated as safety issue: No ]
- To evaluate safety and tolerability of Irosustat by collecting toxicities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03: June 14, 2010) [ Time Frame: Patients will be assesed at baseline, day 7, day 14 and at 30 days following the last dose of Irosustat. Patients who have consented to an optional post treatment tumour biopsy will attend an extra study visit. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Irosustat 40mg OD for a minimum of 2 weeks until follow up FLT-PET/CT. For those patients consented to a repeat tumour biopsy, treatment will be extended to that day before the procedure.
Irosustat will be administered once daily in 40mg tablets. Treatment will start the day after the baseline FLT-PET and will be continued for a minimum of 2 weeks until the follow up FLT PET scan. For those patients who have consented to a repeat tumour biopsy, treatment will be extended to the day before the procedure. Study medication should be taken in the morning under fasting conditions with a glass of water, 30 minutes before breakfast.
To assess changes in [18F] fluorothymidine (FLT) uptake using Positron Emission Tomography (PET) following 2 weeks of Irosustat treatment in patients with early, treatment naïve, oestrogen receptor positive (ER +ve) breast cancer
To assess the:
- Pharmacodynamic profile of Irosustat
- Safety and tolerability of Irosustat
Study Population: Postmenopausal women with early, treatment naïve, ER +ve breast cancer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662726
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Carlo Palmieri, BSc MBBS PhD||Imperial Colllge London|