Active not recruitingPHASE3INTERVENTIONAL

PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

This study, called POETIC-A, is for post-menopausal women with early-stage breast cancer. It's designed for those whose cancer might be harder to treat with standard hormone therapy alone, identified by a test after a short course of medication before surgery. Some patients will receive standard hormone therapy, while others will get hormone therapy plus a new drug called abemaciclib. The main goal is to see if adding abemaciclib can prevent the cancer from returning more effectively than hormone therapy alone. It also aims to understand who might benefit most from this new combined treatment. Taking part involves a two-year treatment period and regular check-ups.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

123

Start

23 Dec 2020

Estimated completion

01 Oct 2030

Breast Cancer Female

What is this study about?

Imagine you or someone you know has been diagnosed with early-stage breast cancer, and you've gone through surgery. The good news is that many women are given hormone therapy afterwards to help stop the cancer from coming back. This treatment, also known as endocrine therapy, is very effective for lots of people. However, for some women, the cancer might eventually find a way around these treatments, meaning there's a higher chance it could return.

The POETIC-A study is designed to help those women for whom standard hormone therapy might not be quite enough. It focuses on women who have gone through menopause and have hormone-sensitive breast cancer. Before surgery, these women will receive a short course of hormone medication. After surgery, a sample of their cancer will be tested. If the test shows that the cancer is still very active, it suggests it might be more likely to return, and these women could benefit from extra treatment.

For those who are identified as being at higher risk, the study will offer two options. Some will continue with standard hormone therapy, which is already a proven treatment. Others will receive hormone therapy alongside a newer drug called abemaciclib. The study wants to find out if adding abemaciclib works better at preventing the cancer from coming back compared to hormone therapy alone. They also want to understand if certain characteristics of a woman's cancer make abemaciclib treatment particularly suitable for them.

Key takeaways

This study is for post-menopausal women with early breast cancer.
It aims to find out if adding abemaciclib to hormone therapy can better stop cancer from returning.
A special test on your cancer after surgery helps decide if you're suitable for the main treatment part.
Participants will be randomly assigned to receive either hormone therapy alone or with abemaciclib.
Treatment with abemaciclib, if in that group, lasts for two years.
Regular check-ups are part of taking part in this study.

Who may be eligible?

This study is specifically designed for women who have gone through menopause. You would need to have been diagnosed with breast cancer that can be operated on, with a tumour of a certain size (at least 1cm). The cancer needs to be a certain type (known as 'hormone-sensitive') and not have spread to other parts of the body. You also can't have had certain other breast cancer treatments before.

Before joining the main part of the study, you would start a hormone medication (anastrozole or letrozole) for a period between 10 days and 6 months before your surgery. If tests on your cancer after surgery suggest you might be at higher risk of the cancer returning, and your cancer is HER2-negative (another specific type), you might then be invited to join the treatment part of the study.

Important things that would mean you couldn't join include being a man, being pre- or peri-menopausal, currently using HRT or other oestrogen-containing medicines, having already had other hormone therapy or chemotherapy for breast cancer, or if your cancer has spread.

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 who has gone through menopause?
Have you been diagnosed with breast cancer that can be operated on?
Is your breast cancer described as 'hormone-sensitive'?
Are you able to start a hormone medication 10 days to 6 months before your surgery?
Do you not have any other medical conditions or take medications that would prevent you from taking part (e.g., HRT)?
Has your cancer not spread to other parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the journey begins with starting a specific hormone medication, such as anastrozole or letrozole, for a period ranging from 10 days to up to 6 months before your breast cancer surgery. After your surgery, a small sample of your tumour will be tested to understand if you might be at a higher risk of the cancer returning.

If the tests show you are at higher risk, you could then be invited to join the main treatment part of the study. If you agree, you'll be randomly assigned to one of two groups: either you'll receive standard hormone therapy, or you'll receive standard hormone therapy plus the new drug abemaciclib. The abemaciclib treatment, if you're in that group, would continue for two years. All participants will have regular check-ups and appointments with the study team during this two-year period, as well as during ongoing follow-up to monitor your health and the effectiveness of the treatment.

Potential risks and benefits

Taking part in a study like this means you might receive a treatment that could be more effective than standard care, especially if you're in the group receiving abemaciclib. However, there's no guarantee that you will benefit from the treatment, and like all medications, abemaciclib and standard hormone therapies can have side effects, which your doctor will discuss with you. You will also have more regular appointments and tests than usual, which can be an extra time commitment. It's important to remember that joining a study is always your choice, and you are free to withdraw at any time without affecting your medical care.

Locations (62)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Cornwall Hospital
Verified postcode
Truro, United Kingdom
Royal Devon & Exeter Hospital
Verified postcode
Exeter, United Kingdom
Queen Elizabeth Hospital
Verified postcode
Kings Lynn, United Kingdom
Great Western Hospital
Verified postcode
Swindon, United Kingdom
Northampton General Hospital
Verified postcode
Northampton, United Kingdom
Belfast City Hospital
Verified postcode
Belfast, United Kingdom
Forth Valley Royal Hospital
Verified postcode
Larbert, United Kingdom
Royal Surrey County Hospital
Verified postcode
Guildford, United Kingdom
Aberdeen Royal Infirmary
Verified postcode
Aberdeen, United Kingdom
Wansbeck General Hospital
Verified postcode
Ashington, United Kingdom
Ysbyty Gwynedd
Verified postcode
Bangor, United Kingdom
Royal United Hospital Bath
Verified postcode
Bath, United Kingdom

Common questions

What is hormone therapy?

Hormone therapy, or endocrine therapy, is a treatment that helps stop breast cancer cells from growing by blocking or lowering the level of certain hormones in the body that can fuel cancer growth.

What is abemaciclib?

Abemaciclib is a targeted drug that works in a different way to stop cancer cells from dividing and growing. In this study, it's being tested to see if it can boost the effects of standard hormone therapy.

Why do you test the cancer tissue?

Testing the cancer tissue helps the study doctors understand how active the cancer cells are and whether they are likely to respond well to standard hormone therapy. This helps identify who might benefit most from additional treatments like abemaciclib.

Will I know which treatment I'm getting?

Once you join the main treatment part of the study, you will be randomly assigned to one of the two treatment groups. Your study doctor will tell you which treatment you will receive.

How long will the study last for me?

If you join the treatment part, you would take the study medication for two years. There will also be regular follow-up appointments after this two-year period to monitor your health.