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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior bilateral oophorectomy
Amenorrhea > 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe & effective in treating breast cancer that's spread or come back.
Who is the study for?
This trial is for postmenopausal women over 18 with AR+/HER2-/ER+ breast cancer that's advanced or metastatic and has no standard treatment options left. They must have a biopsy-proven diagnosis, be amenorrheic with an intact uterus, or have had a bilateral oophorectomy. Women under 55 who've had a hysterectomy must show postmenopausal hormone levels.Check my eligibility
What is being tested?
The study tests EP0062 as a single therapy to find the best dose and evaluate its safety, tolerability, how the body processes it (pharmacokinetics), and effectiveness in patients with specific types of advanced breast cancer.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects for new cancer therapies may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems. Specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had both of my ovaries surgically removed.
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I have not had a period for over a year, and my hormone levels confirm I am postmenopausal.
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I am over 60 years old.
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My breast cancer is HER2-negative based on specific tests.
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My breast cancer is AR+ with at least 30% of cells showing AR by a specific test.
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I can provide a sample of my tumor, or I am willing to have a new biopsy if needed.
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My breast cancer is positive for both AR and ER.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment
Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts
Secondary outcome measures
Clinical Benefit Rate (CBR)
Objective Response Rate (ORR)
Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure)
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Module B - EP0062 Dose level 2Experimental Treatment1 Intervention
Patients randomised to one of the 2 expansion doses selected from Module A, with up to 30 patients included per dose level, to further characterise the safety and efficacy of EP0062.
Group II: Module B - EP0062 Dose level 1Experimental Treatment1 Intervention
Patients randomised to one of the 2 expansion doses selected from Module A, with up to 30 patients included per dose level, to further characterise the safety and efficacy of EP0062.
Group III: Module A - EP0062 Dose FindingExperimental Treatment1 Intervention
Patients are assigned to dose level cohorts to identify MTD and assess safety, tolerability and PK profile.
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Who is running the clinical trial?
Ellipses PharmaLead Sponsor
4 Previous Clinical Trials
349 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had both of my ovaries surgically removed.I have not had a period for over a year, and my hormone levels confirm I am postmenopausal.I am over 60 years old.My breast cancer is HER2-negative based on specific tests.My breast cancer is AR+ with at least 30% of cells showing AR by a specific test.My breast cancer is advanced or has spread, and I can't or won't use standard treatments.My hormone levels indicate I am postmenopausal, and I am under 55 with a hysterectomy.I can provide a sample of my tumor, or I am willing to have a new biopsy if needed.I am postmenopausal.I don't have serious side effects from previous cancer treatments, except for tiredness, hair loss, or mild nerve pain.I am not on medications that affect heart rhythm and can't be stopped.I have not had a heart attack or unstable chest pain in the last 6 months.I am a woman aged 18 or older.I haven't taken any cancer drugs or been in a drug trial recently.I am currently on medications like testosterone or hormonal treatments.I haven't had radiation therapy in the last 14 days but may have it during the study.My breast cancer is positive for both AR and ER.My heart condition is classified between moderate to severe.My heart's electrical activity is mostly normal, except for controlled atrial fibrillation.I am not taking strong medication that affects liver enzymes within the last 14 days.My breast cancer is AR+ with at least 10% of cells showing AR.I have a heart condition related to abnormal ECG results or a family history of sudden cardiac death.
Research Study Groups:
This trial has the following groups:- Group 1: Module A - EP0062 Dose Finding
- Group 2: Module B - EP0062 Dose level 2
- Group 3: Module B - EP0062 Dose level 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can patients sign up for this trial right now?
"According to the latest information available on clinicaltrials.gov, this particular study is not looking for new patients at this time. The original posting date was December 1st, 2022 and there have been no updates since October 5th, 2022. There are 2384 other trials that are still recruiting patients."
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