SFX-01 in the Treatment of ER positive Metastatic Breast Cancer - V1.0
Research type
Research Study
Full title
STEM: A Multicentre Phase 2 Study of SFX-01 Treatment in Patients with Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on either an Aromatase Inhibitor (AI), Tamoxifen or Fulvestrant
IRAS ID
208418
Contact name
Sacha Jon Howell
Contact email
Sponsor organisation
Evgen Pharma PLC
Eudract number
2015-004851-28
Duration of Study in the UK
1 years, 7 months, 2 days
Research summary
Approximately 75% of metastatic breast cancers express the estrogen receptor (ER). Initially, many such cancers can be controlled using endocrine therapies such as tamoxifen, fulvestrant and the aromatase inhibitors (AIs; letrozole, anastrazole and exemestane). However, resistance almost always develops, ultimately leading to the death of such patients. Endocrine resistance is mediated in part by the persistence of ER negative breast cancer stem cells. In laboratory studies SFX-01 has been shown to inhibit the activity of such cancer stem cells and to enhance the effectiveness of endocrine therapies. The active component of SFX-01 is sulphoraphane, a well-known substance contained in broccoli and other cruciferous vegetables, although the levels of sulporophane in the body after taking SFX-01 will be much higher than those achieved by eating broccoli. SFX-01 is in the early stages of development and this is the first time it is being given to breast cancer patients. Approximately 60 participants (women and men) from 10 European centres will be recruited to the study. At study entry the participants’ cancers will be progressing (growing) on treatment with endocrine therapy and SFX-01 will be added to this treatment to see whether resistance can be reversed and the tumour growth halted. The study will also test how safe and well tolerated SFX-01 is in combination with the three different types of endocrine therapy. The study has three different treatment arms (tamoxifen, fulvestrant and AI) depending on which drug patients are taking at the time they enter the study and there will be about 20 patients in each arm.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0443
Date of REC Opinion
7 Dec 2016
REC opinion
Further Information Favourable Opinion