A study to assess the effects of enobosarm on early breast cancer
| ISRCTN | ISRCTN12213700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12213700 |
| Clinical Trials Information System (CTIS) | 2016-000543-13 |
| Protocol serial number | 31856 |
| Sponsor | University of Liverpool |
| Funder | Cancer Research UK |
- Submission date
- 23/01/2017
- Registration date
- 26/01/2017
- Last edited
- 09/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Department of Molecular and Clinical Cancer Medicine
Institute of Translational Medicine
Faculty of Health and Life Sciences
University of Liverpool
Sherrington Building
Ashton Street
Liverpool
L69 3GE
United Kingdom
| Phone | +44 151 706 3616 |
|---|---|
| c.palmieri@liv.ac.uk |
Public
Cancer Research UK: Liverpool Cancer Trials Unit
Block C Waterhouse Building
1-3 Brownlow Street
University of Liverpool
Liverpool
L69 3GL
United Kingdom
| Phone | +44 151 794 8209 |
|---|---|
| emeraldtrial@liverpool.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Drug |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A window of opportunity study to assess the biological effects of enobosarm in oestrogen receptor positive, androgen receptor positive early breast cancer |
| Study acronym | EMERALD |
| Study objectives | The aim of this study is to determine the effect of enobosarm, a selective androgen receptor modulator, using a "window of opportunity study" in women with early breast cancer. |
| Ethics approval(s) | North West – Haydock Research Ethics Committee, 28/12/2016, ref: 16/NW/0807 |
| Health condition(s) or problem(s) studied | Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast |
| Intervention | Current interventions as of 24/09/2018: Patients are screened, consented and then randomised onto the trial using the LCTUs TARDIS (Treatment Allocation RanDomIsation System) which for EMERALD uses randomly permuted blocks based on stratified lists to a ratio of 3:1 (treatment : standard of care). Treatment arm: Patients will take 9 mg of enobosarm capsules orally every day for 14 (+4) days, before pre-scheduled surgery/research core biopsy (within 24 hours of last dose). Patients will be followed up for 14 days after surgery/research core biopsy for adverse events. Blood (20 ml or about 4 teaspoons) will be taken at the Baseline Visit (Day 1) and the Tissue Collection Visit (Day 14). The sample from the core biopsy (FFPE block) will be requested to measure Ki67 at baseline and a sample (FFPE block) will be taken from the surgical specimen/research core biopsy specimen. Standard care arm: Patients will have their pre-scheduled surgery/research core biopsy as planned after 14 (+4) days. Blood (20 ml or about 4 teaspoons) will be taken at the Baseline Visit (Day 1) and the Tissue Collection Visit (Day 14). The sample from the core biopsy (FFPE block) will be requested to measure Ki67 at baseline and a sample (FFPE block) will be taken from the surgical specimen/research core biopsy specimen. Previous interventions: Patients are screened, consented and then randomised onto the trial using the LCTUs TARDIS (Treatment Allocation RanDomIsation System) which for EMERALD uses randomly permuted blocks based on stratified lists to a ratio of 3:1 (treatment : standard of care). Treatment arm: Patients will take 9mg of enobosarm capsules orally every day for 14(+4) days, before pre-scheduled surgery (within 24 hours of last dose). Patients will be followed up for 14 days after surgery for adverse events. Blood (20ml or about 4 teaspoons) will be taken at the baseline visit (Day 1), the mid-treatment visit (Day 7) and the surgery visit (Day 14). The sample from the core biopsy (FFPE block) will be requested to measure Ki67 at baseline and a sample (FFPE block) will be taken from the surgical specimen. Standard care arm: Patients will have their pre-scheduled surgery as planned after 14 (+4) days. Blood (20ml or about 4 teaspoons) will be taken at the baseline visit (Day 1), the mid-treatment visit (Day 7) and the surgery visit (Day 14). The sample from the core biopsy (FFPE block) will be requested to measure Ki67 at baseline and a sample (FFPE block) will be taken from the surgical specimen. |
| Intervention type | Other |
| Primary outcome measure(s) |
Current primary outcome measure as of 24/09/2018: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 24/09/2018: |
| Completion date | 31/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 147 |
| Key inclusion criteria | Current inclusion criteria as of 24/09/2018: 1. Females 16 years of age or older 2. Histologically confirmed ER positive breast cancer (Allred ≥3) 3. AnR positive breast cancer (defined as ≥10% nuclear AnR staining by immunohistochemistry) 4. Any HER2 status 5. Tumour measuring ≥14 mm in longest diameter by ultrasound (US) examination, MRI or mammogram 6. Postmenopausal as defined by one of the following criteria: 6.1. Women ≥55 years of age with an intact uterus and amenorrhoea ≥12 months at the time of diagnosis (or documented or current FSH and oestradiol levels within the postmenopausal range (as per local institutional/laboratory standard)) 6.2. Prior bilateral oophorectomy 6.3. Documented or current FSH and oestradiol levels within the postmenopausal range (as per local institutional/laboratory standard) in women aged <55 years or in women who have had a hysterectomy with intact ovaries 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 8. Adequate renal function defined by a serum creatinine ≤1.5 x ULN. Adequate liver function defined by total bilirubin ≤1.5 ULN (patients with Gilbert’s Syndrome exempted), either ALT or AST ≤2.5 ULN and ALP ≤2.5 ULN 9. Acceptable risk of bleeding (e.g. bleeding diathesis, warfarin) as assessed by the PI (if the PI is unsure the CI will make the final decision) 10. Written informed consent 11. Able to comply with treatment and follow up Previous inclusion criteria: 1. Females 16 years of age or older 2. Histologically confirmed ER positive breast cancer (Allred ≥3) 3. AnR positive breast cancer (defined as ≥10% nuclear AnR staining by immunohistochemistry) 4. Any HER2 status 5. Tumour measuring ≥14mm in longest diameter by ultrasound (US) examination, MRI or mammogram 6. Postmenopausal as defined by one of the following criteria: 6.1. Amenorrhoea >12 months at the time of diagnosis and an intact uterus, with FSH and oestradiol in the postmenopausal ranges 6.2. Prior bilateral oophorectomy 6.3. FSH and oestradiol levels within the postmenopausal range (as per local practice) in women aged <55 years who have undergone hysterectomy 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 8. Adequate renal function defined by a serum creatinine ≤1.5 x ULN. Adequate liver function defined by total bilirubin ≤ 1.5 ULN (patients with Gilbert’s Syndrome exempted), either ALT or AST ≤2.5 ULN and ALP ≤2.5 ULN 9. Acceptable risk of bleeding (e.g. bleeding diathesis, warfarin) as assessed by the PI (and where the PI is unsure the CI) 10. Written informed consent 11. Able to comply with treatment and follow up |
| Key exclusion criteria | Current exclusion criteria as of 24/09/2018: 1. Inoperable breast cancer 2. Males 3. Inflammatory tumours 4. Evidence of metastatic disease 5. Any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ) 6. Prior endocrine therapy of chemotherapy for breast cancer 7. Concomitant use (defined as use within 12 weeks prior to entry) of HRT or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens) 8. Previous use of oestrogen implants within the last 12 weeks 9. Uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels 10. Evidence of uncontrolled active infection 11. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial 12. Participation in a clinical trial of an IMP in the last 30 days Previous inclusion criteria: 1. Inoperable breast cancer 2. Inflammatory tumours 3. Evidence of metastatic disease 4. Any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ) 5. Evidence of bleeding diathesis 6. Prior endocrine therapy of chemotherapy for breast cancer 7. Concomitant use (defined as use within 12 weeks prior to entry) of HRT or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens) 8. Previous use of oestrogen implants at ANY time 9. Uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels 10. Evidence of uncontrolled active infection 11. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial 12. Participation in a clinical trial of an IMP in the last 30 days |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Liverpool
L7 8XP
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Manchester
M8 5RB
United Kingdom
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
Chester Health Park
Chester
CH2 1UL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request following the process laid out on the LCTU website here or LCTU.org.uk > About the LCTU > Data Sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 6.0 | 17/05/2021 | 09/01/2023 | No | No |
Additional files
- ISRCTN12213700_Protocol_v6.0_17May2021.pdf
- Protocol file
Editorial Notes
09/01/2023: Protocol file uploaded.
25/02/2018: The recruitment end date has been changed from 30/05/2018 to 28/02/2019.
24/09/2018: The following changes have been made:
1. Greg Gibson has been replaced by Ediri O’Brien as the public contact.
2. The interventions have been changed.
3. The primary outcome measures have been changed.
4. The secondary outcome measures have been changed.
5. The overall trial end date has been changed from 30/11/2018 to 31/05/2019.
6. The participant inclusion criteria have been changed.
7. The Target number of participants has been changed from 146 to 147.
8. The participant exclusion criteria have been changed.
9. University Hospital of South Manchester, Macclesfield District General Hospital, North Manchester General Hospital, Clatterbridge Hospital and Countess of Chester Hospital NHS Foundation Trust have been added to the trial centres.
16/10/2017: Cancer Help UK lay summary link added to plain English summary field
15/09/2017: Internal review.
06/06/2017: Internal review.
