A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
This study is for people in the UK who have had HR-positive/HER2-negative breast cancer removed by surgery within the last five years and are at higher risk of it coming back. It aims to see if new treatments can help. Doctors will take regular blood samples to check for tiny amounts of cancer cells (called ctDNA). If these are found, some patients will be invited to take part in the treatment part of the study. They will receive either a control treatment or one of three new drug combinations: Giredestrant, Giredestrant with Abemaciclib, or Giredestrant with Inavolisib. The study hopes to learn if treating these tiny traces of cancer early can prevent the cancer from fully returning.
At a glance
What is this study about?
This study focuses on a type of breast cancer called HR-positive/HER2-negative, which has been removed by surgery. Even after surgery, some people have a higher chance of their cancer returning. This study wants to find out if there's a better way to spot this early and, crucially, if giving new treatments at that point can stop the cancer from coming back.
The study involves two main parts. First, if you join, doctors will regularly take blood samples. They will check these samples for very small amounts of cancer DNA, called ctDNA. This is a very sensitive test that can sometimes pick up traces of cancer even before it can be seen on scans or felt physically. This monitoring phase will last for several years, with blood tests initially every three months, then every six months.
If ctDNA is found in your blood, and you meet further criteria, you might be invited to join the second part of the study: the treatment phase. In this phase, a small group of patients will be given one of the new experimental treatments or a control. The researchers want to see if these treatments can get rid of these tiny traces of cancer and prevent the cancer from returning more seriously. This is a 'proof of concept' study, meaning it’s a first step to see if this approach works, which could then lead to larger studies in the future.
Key takeaways
- This study is for people with HR-positive/HER2-negative breast cancer after surgery.
- It uses advanced blood tests to detect tiny traces of cancer (ctDNA) early.
- If ctDNA is found, you might receive new experimental treatments.
- The goal is to see if early treatment can stop cancer from returning.
- Participation involves regular blood tests and possibly new medication.
Who may be eligible?
This study is looking for both men and women aged 18 or over. You must have had HR-positive/HER2-negative early-stage breast cancer that has been removed by surgery within the last five years. Importantly, you shouldn't have any current signs of cancer spread and should have been taking hormone therapy for at least two years but no more than seven, with a plan to continue for three more years.
You're a good fit if your cancer was considered 'high risk' of returning, for example, based on the number of lymph nodes affected or the size and grade of the tumour. If you've previously had chemotherapy before surgery and still had some cancer cells left, you might also be eligible.
Even if you haven't been part of the initial blood monitoring phase, if you've already had a blood test (outside of this study) that shows traces of cancer DNA (ctDNA) and that's confirmed by the study's test, you might be able to go straight into the treatment part of the study, provided you meet all other criteria.
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 18 or older?
- Have you had HR-positive/HER2-negative breast cancer surgery within the last 5 years?
- Are you currently taking hormone therapy for breast cancer (2-7 years so far, with 3 more planned)?
- Was your breast cancer considered high-risk of coming back?
- Do you have no current signs of cancer when checked (no spread)?
- Are you able to provide blood samples regularly?
What does participation involve?
If you join the study, you'll first enter a 'surveillance phase'. This means you’ll have regular blood tests – every three months for the first year, then every six months – to check for cancer DNA (ctDNA). This monitoring will continue until ctDNA is found or until the study's monitoring period ends. We'll also collect a sample of your original tumour and a normal blood sample to help create a unique 'fingerprint' of your cancer.
If ctDNA is found in your blood and you meet all other requirements, you could then be invited to join the second, 'treatment phase'. There are four possible groups you could be placed into, chosen randomly: a control group or groups receiving new treatments (Giredestrant alone, Giredestrant with Abemaciclib, or Giredestrant with Inavolisib). All treatments are given as tablets. The study will involve regular check-ups, blood tests, and possibly scans to see how you are responding. The total duration of your participation will depend on which phase you are in and how you respond to treatment.
Potential risks and benefits
Locations (41)
- Complejo Hospitalario Universitario A Coruña (CHUAC)Verified postcodeA Coruña, Spain· Recruiting
- Hospital General Universitario Dr. BalmisVerified postcodeAlicante, Spain· Recruiting
- Hospital Marina Salud de DeniaVerified postcodeAlicante, Spain· Recruiting
- Hospital Virgen de los LiriosVerified postcodeAlicante, Spain· Recruiting
- Fundació AlthaiaVerified postcodeBarcelona, Spain· Recruiting
- Hospital Clínic i Provincial de BarcelonaVerified postcodeBarcelona, Spain· Recruiting
- Hospital Universitari DexeusVerified postcodeBarcelona, Spain· Recruiting
- Hospital Universitario de BasurtoVerified postcodeBilbao, Spain· Recruiting
- Hospital Provincial de CastellónVerified postcodeCastellon, Spain· Recruiting
- Hospital Universitario Reina SofíaVerified postcodeCórdoba, Spain· Recruiting
- Hospital del VinalopóVerified postcodeElche, Spain· Recruiting
- Institut Català d' Oncologia Girona (ICO)Verified postcodeGirona, Spain· Recruiting
Common questions
What does HR-positive/HER2-negative mean?
It describes a common type of breast cancer that responds to hormones (HR-positive) but doesn't have too much of a protein called HER2 (HER2-negative). This affects how it's treated.
What is 'ctDNA'?
CtDNA stands for 'circulating tumour DNA'. It's tiny pieces of cancer cells' DNA that can be found in your blood. Finding it can sometimes show that cancer cells are present, even if they're too small to see on scans.
What are 'experimental arms'?
These are groups in the study that receive new treatments that are not yet widely available. The study compares these new treatments to a 'control arm' which might receive standard care or a placebo.
Will I have to pay to be part of this study?
No, all study-related treatments, tests, and visits are covered by the study sponsor. You will not have to pay.
How long will I be in the study?
The monitoring phase can last several years, with blood tests every three to six months. If you enter the treatment phase, your time in the study will depend on the specific treatment plan and how you respond.
How to find out more
Medsir
Always speak to your GP or specialist before deciding to take part in a study.
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