Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
This study is looking into a new medication called EP0062 for women with advanced or metastatic breast cancer. This type of cancer has specific characteristics: it's Hormone Receptor-positive (ER+), HER2-negative, and Androgen Receptor-positive (AR+). The main goal is to figure out the best dose of EP0062, either by itself or when given alongside other common treatments. Researchers want to understand how safe the medicine is, how well people tolerate it, and how effective it might be in treating the cancer. The study is split into stages, with the first stage already completed to help choose the most promising dose for further investigation.
At a glance
What is this study about?
This research study is focused on a new potential treatment called EP0062 for a specific type of advanced breast cancer. This cancer is described as 'Hormone Receptor-positive (ER+)' meaning it's sensitive to hormones, 'HER2-negative' meaning it doesn't have too much of a protein called HER2, and 'Androgen Receptor-positive (AR+)' which means it's also sensitive to male hormones. When cancer is advanced or metastatic, it means it has spread from its original site to other parts of the body.
The main purpose of this study is to carefully examine EP0062. The doctors want to find the safest and most effective amount (dose) of this new medicine. They are looking at EP0062 both on its own and when given together with other treatments that are currently used for breast cancer. The study will assess how well patients tolerate EP0062, what effects it has on the body, and how successful it is at treating the cancer.
This study is happening in stages (Phase 1 and Phase 2). The first stage, Phase 1, has already been completed, which helped the researchers identify a suitable dose of EP0062 to study further. Now, in Phase 2, they will continue to evaluate this dose more broadly in patients to understand its benefits and side effects when used in their specific cancer condition.
Key takeaways
- This study is testing a new drug, EP0062, for advanced breast cancer.
- It focuses on a specific type of breast cancer that is AR+, HER2-, and ER+.
- The main goals are to find the best dose and check the safety and effectiveness of EP0062.
- EP0062 is being tested both alone and with other standard cancer treatments.
- You must be a postmenopausal woman with this specific type of advanced breast cancer to be considered.
- The first stage of finding the best dose for the drug has already been completed.
Who may be eligible?
To join this study, you would need to be a woman aged 18 or older. You must have been diagnosed with advanced or metastatic breast cancer that has spread, and where standard treatments aren't suitable, aren't working, or you've decided against them. Your cancer must also have specific features: it needs to be positive for hormone receptors (ER+) and androgen receptors (AR+), but negative for the HER2 protein.
Doctors will need to check your cancer tissues to confirm these features. For the AR+ status, the amount of androgen receptor protein found in your tumour tissue is important and may vary depending on which part of the study you might join. You also need to be postmenopausal, either naturally, after a hysterectomy or ovary removal, or if you are over 60.
If you are in a specific part of the study (Module B arm 1), you would have tried up to two hormone-blocking treatments before, including a type of medicine called a CDK4/6 inhibitor, and your cancer has progressed.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman aged 18 or over?
- Do you have advanced or metastatic breast cancer?
- Is your breast cancer Hormone Receptor-positive (ER+), HER2-negative, and Androgen Receptor-positive (AR+)?
- Are you postmenopausal (e.g., over 60, or without periods for over 12 months, or had ovaries removed)?
- Have you had up to 2 previous hormone treatments including a CDK4/6 inhibitor for your cancer (for Module B arm 1)?
- Is your doctor able to get a sample of your cancer tissue for testing?
What does participation involve?
Taking part in this study would involve regular visits to the clinic for check-ups and assessments. You would be given the study medication, EP0062, which you would take as directed. Depending on the part of the study, you might also receive other standard breast cancer treatments alongside EP0062. Doctors will monitor you closely to see how you respond to the treatment and to keep an eye on any side effects. The exact number of visits, tests, and the total length of your participation would be fully explained by the study team before you decide to join.
Potential risks and benefits
Locations (14)
- Yale School of MedicineVerified postcodeNew Haven, United States· Completed
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- Henry Ford HospitalVerified postcodeDetroit, United States· Recruiting
- Sarah Cannon Research InstituteVerified postcodeNashville, United States· Recruiting
- Texas Oncology Baylor University Medical CenterVerified postcodeDallas, United States· Recruiting
- Virginia Cancer SpecialistsVerified postcodeFairfax, United States· Recruiting
- Hospital 12 de OctubreVerified postcodeUsera, Spain· Recruiting
- Hospital Universitari Vall d'Hebron (VHIO)Verified postcodeBarcelona, Spain· Recruiting
- Hospital Universitario Ramón y CajalVerified postcodeMadrid, Spain· Recruiting
- NEXT Oncology Hospital QuironsaludVerified postcodeMadrid, Spain· Recruiting
- Sarah Cannon Research Institute UKVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What does 'advanced or metastatic breast cancer' mean?
This means your breast cancer has spread from where it started to other parts of your body.
What does 'AR+/HER-2-/ER+ breast cancer' mean?
It describes specific features of your cancer: it's sensitive to hormones (ER+), sensitive to male hormones (AR+), but doesn't have too much of a protein called HER2 (HER-2 negative).
What is EP0062?
EP0062 is a new medicine being tested in this study to see if it can treat your specific type of breast cancer.
Will I have to pay for the treatment?
No, all study-related treatments and assessments are provided free of charge.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, and your decision will not affect your future medical care.
How to find out more
Clinical Trials Team
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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