Condition category
Cancer
Date applied
23/01/2017
Date assigned
26/01/2017
Last edited
16/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Carlo Palmeiri

ORCID ID

Contact details

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
+44 151 706 3616
c.palmieri@liv.ac.uk

Type

Public

Additional contact

Mr Greg Gibson

ORCID ID

Contact details

Cancer Research UK: Liverpool Cancer Trials Unit
Block C Waterhouse Building
1-3 Brownlow Street
University of Liverpool
Liverpool
L69 3GL
United Kingdom
+44 151 795 5289
emeraldtrial@liverpool.ac.uk

Additional identifiers

EudraCT number

2016-000543-13

ClinicalTrials.gov number

Protocol/serial number

31856

Study information

Scientific title

A window of opportunity study to assess the biological effects of enobosarm in oestrogen receptor positive, androgen receptor positive early breast cancer

Acronym

EMERALD

Study hypothesis

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

North West – Haydock Research Ethics Committee, 28/12/2016, ref: 16/NW/0807

Study design

Randomised; Interventional; Design type: Treatment, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast

Intervention

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

Phase

Phase II

Drug names

Primary outcome measures

Reduction in the proliferation marker Ki67 (% positive tumour cells) determined by tissue immunohistochemistry at baseline and 2 weeks.

Secondary outcome measures

1. Amount of cleaved caspase 3 determined by tissue immunohistochemistry at baseline and two weeks
2. Expression of PSA, Gross Cystic Disease Fluid Proteins (GCDFP)-24 &-15; PgR, GREB1 by tissue immunohistochemistry at baseline and two weeks
3. Amount in plasma levels of circulating steroidogenic hormones oestradiol, oestrone, oestrone sulfate, androstenedione, follicle stimulating hormone, luteinizing hormone, DHT, progesterone, sex hormone binding globulin (SHBG) and total testosterone in blood determined by blood assay at baseline and two weeks; free testosterone to be derived from SHBG and total testosterone
4. Amount in plasma levels of PSA and steroidogenic hormones determined by blood assay at baseline and two weeks

Overall trial start date

11/12/2015

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant 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)[1]
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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 146; UK Sample Size: 146

Participant exclusion 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

Recruitment start date

01/03/2017

Recruitment end date

30/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Liverpool Cancer Trials Unit
Block C, Waterhouse Building 1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

1-3 Brownlow Street
Liverpool
L69 3BX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

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.

Intention to publish date

30/11/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.