At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- EP0062 (drug), Elacestrant (drug), Everolimus (drug), Abemaciclib (drug)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- EP0062 — drug: EP0062 is an orally administered investigational selective androgen receptor modulator (SARM) · Elacestrant — drug: Oral SERD · Everolimus — drug: mTOR Inhibitor · Abemaciclib — drug: CDK4/6 inhibitor · Fulvestrant — drug: Oral SERD · Exemestane — drug: aromatase inhibitor
- Patient visit burden
- Not specified by the sponsor
In plain English
This early-stage (Phase 1/2) study is testing a new drug called EP0062, on its own and in combination with other treatments, in women with advanced or spread (metastatic) breast cancer that is hormone receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-negative). It is funded by Ellipses Pharma.
Who can take part
- Women aged 18 or over
- Breast cancer that has spread or is locally advanced, and no standard treatment is available, suitable, or wanted by the patient
- A stored tumour sample is available, or the patient can have a new biopsy if not
- Cancer tests positive for androgen receptors (AR+) and oestrogen receptors (ER+), with minimum levels of AR staining depending on the study part
- Cancer tests negative for HER2
- Patients must be past the menopause (rules based on age, periods stopping, hormone blood tests, or having had both ovaries removed)
- For some parts of the study, patients must have already been treated with hormone therapy and/or a CDK4/6 inhibitor drug that stopped working
Who may not be able to
- Recent cancer treatment before the study starts (chemotherapy, tamoxifen, aromatase inhibitors, fulvestrant, or other experimental drugs within set time limits)
- Currently taking testosterone or similar hormones, or anti-androgen medicines
- Radiotherapy within 14 days before starting, or planned during the study (short palliative courses may be allowed)
- Ongoing serious side effects from earlier treatment, other than tiredness, hair loss, or certain nerve problems
- Certain heart conditions, including a long QT interval on a heart trace, some heart rhythm problems, heart failure, or a recent heart attack or unstable angina
- Taking certain medicines that affect the QT interval or that strongly affect how the body processes the study drug, if they cannot be stopped or swapped
- Previous treatment with the selected combination drug
What taking part involves
- • Taking the study drug EP0062, either on its own or in combination with another treatment
- • Having tests such as heart traces (ECG) and tumour biopsies
- • Attending study visits at a hospital or clinic for checks and treatment
Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 95
- Started
- 2023-01-11
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for hormone receptor-positive breast cancer
- • Phase1/Phase2 - 95 participants
- • The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hormone receptor-positive breast cancer
- • Female only
Where?
- • London - Sarah Cannon Research Institute UK
- • Manchester - The Christie NHS Foundation Trust
- • Liverpool - The Clatterbridge Cancer Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
More detail
EP0062 is being investigated in this modular, interventional, open label, Phase 1/2 dose finding, optimisation and expansion study to determine the optimal dose of EP0062 given as monotherapy and for evaluation in combination with standard-of-care therapies in patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer. Module A (phase 1 dose finding) has completed and an optimal dose has been selected for module B (phase 2 expansion).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Women 18 years or older at the time of agreement to take part
- ✓Biopsy-proven AR+ and ER+ breast cancer
- ✓For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using...
- ✓For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay
- ✓Postmenopausal, as defined by at least one of the following:
Who cannot take part
- ✗Patients with any of the following will not be included in the study:
- ✗Prior anti-cancer or investigational drug treatment within the following time windows:
- ✗Any drug treatment within 21 days prior to the first dose of the study treatment
- ✗Any non-drug treatment investigational anti-cancer drug \< 5 half-lives (28 days for biologics) or \< 14 days for...
- ✗Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of the study treatment
See the full criteria
Where Is This Study? (3 UK sites)
Sarah Cannon Research Institute UK
London W1G 6AD, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
The Clatterbridge Cancer Centre
Liverpool CH63 4JY, United Kingdom
How to Get in Touch
Clinical Trials Team
Sponsor contactCONTACT
