RecruitingInterventional

Optimal personalised treatment of early breast cancer using multiparameter analysis

Chemotherapy is often recommended after breast cancer surgery to prevent the cancer from coming back. However, chemotherapy causes harsh side effects, and not everyone truly needs it. This trial, called OPTIMA, investigates whether a personalised tumour test can safely identify which premenopausal women aged 35 to 54 can avoid chemotherapy. Participants are placed into one of two groups. One group receives the standard treatment: chemotherapy followed by hormone therapy. The second group has their tumour tissue tested for specific genes that predict how likely the cancer is to return. Women with higher-risk scores receive chemotherapy and hormone therapy, while those with lower-risk scores receive hormone therapy alone. The goal is to show that this gene test can spare many women the burden of chemotherapy without compromising their chances of staying cancer-free.

At a glance

Status

Recruiting

Sponsor

University College London

Enrolment target

5,000

Start

05 Sep 2012

Estimated completion

30 Sep 2029

Breast cancer

What is this study about?

Breast cancer is the most common cancer in the UK. When it is caught early, surgeons can remove the tumour completely. After surgery, doctors often suggest extra treatments to destroy any stray cancer cells that might remain. For many years, the standard approach has been chemotherapy followed by several years of hormone therapy tablets. While this saves lives, chemotherapy can cause distressing side effects like extreme fatigue, sickness, hair loss, and an increased risk of infections.

Doctors now know that every breast cancer is unique. Some tumours grow slowly and respond very well to hormone therapy alone. For these tumours, chemotherapy may offer little to no extra benefit. In this study, scientists are using an advanced tumour test that looks at a panel of genes in the cancer cells. This test calculates an individual risk score to show how likely the cancer is to return.

The trial wants to find out if using this test to make treatment decisions is just as safe as giving chemotherapy to everyone. If the test shows that a patient has a low risk of cancer recurrence, she can safely avoid chemotherapy and take hormone therapy tablets instead. Those with a higher risk score will still receive chemotherapy to give them the best possible protection.

By matching the treatment to the specific biology of each tumour, researchers hope to improve women's quality of life, reduce unnecessary treatments, and ensure each person receives the right level of care.

Key takeaways

The trial tests if a tumour gene test can help premenopausal women safely avoid chemotherapy.
It is open to women aged 35 to 54 with ER-positive, HER2-negative early breast cancer.
No extra surgery is needed because the test uses your existing tumour tissue sample.
Participants receive either standard chemotherapy and hormone therapy, or test-directed treatment.
Taking part is completely voluntary and you will be closely monitored throughout.

Who may be eligible?

This trial is open to women aged 35 to 54 who have not yet gone through the menopause. You must have already had surgery to remove an early-stage, invasive breast cancer, and your doctor must consider chemotherapy a suitable next step for you.

Your tumour must be oestrogen-receptor positive (ER-positive) and HER2-negative. These details are checked routinely by the hospital laboratory after surgery. The cancer must also meet specific criteria regarding tumour size and whether it has spread to the lymph nodes in your armpit. For example, you may be eligible if cancer was found in 1 to 9 lymph nodes, or if no lymph nodes were affected but the tumour was at least 30 millimetres in size.

You cannot join if you have already completed menopause, if your tumour has different hormone receptor characteristics, or if you have other health conditions that would make chemotherapy unsafe. Your hospital doctor can check your pathology report to see if you meet all the 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.

I am a woman aged between 35 and 54.
I have not yet gone through the menopause.
I have had surgery to remove an early-stage breast cancer.
My cancer is ER-positive and HER2-negative.
My medical team has suggested chemotherapy as a possible treatment.

Answer every question to see your result.

What does participation involve?

Taking part does not require any extra surgery, because the laboratory test uses tumour samples that were already removed during your previous operation. If you join, a computer will place you at random into one of two groups: standard treatment or test-guided treatment. Depending on your group and test results, you will either receive chemotherapy followed by hormone therapy, or hormone therapy alone. Chemotherapy is usually given by a drip in hospital every few weeks over a 3 to 6 month period. Hormone therapy consists of daily tablets taken at home for at least 5 years. You will attend regular hospital appointments for check-ups, blood tests, and routine scans to closely monitor your health. Your care team will follow your progress for several years.

Potential risks and benefits

The main benefit of taking part is that you may safely avoid chemotherapy and its unpleasant side effects, such as hair loss, nausea, and tiredness, if the test shows you are at low risk. However, there is a possibility that skipping chemotherapy might slightly raise the chance of cancer returning in the future, which is what this study is carefully testing. If you do receive chemotherapy, you will face standard treatment side effects, which your care team will help manage. Joining the study is entirely your choice. You are free to leave at any point without giving a reason, and your normal NHS medical care will continue unaffected.

Locations (1)

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

Warwick Clinical Trials Unit
City only
Coventry, England

Common questions

What is the main goal of this clinical trial?

The study aims to find out if a tumour gene test can safely pick out which women do not need chemotherapy, protecting them from unnecessary side effects.

Do I need another operation to take part?

No. The laboratory runs the test on tumour tissue that was already removed and stored during your original breast surgery.

Can I pick which treatment group I join?

No. A computer assigns you to a group by chance. This random process ensures that the study results are fair and reliable.

What is hormone therapy?

Hormone therapy is a standard treatment for ER-positive breast cancer. It involves taking daily tablets, usually for 5 years or more, to block hormones that can fuel cancer growth.

What happens if I change my mind after joining?

You can leave the trial at any time. Your doctors will fully support your decision and discuss standard treatment options with you right away.

How to find out more

Georgina Dotchin

OPTIMA@warwick.ac.uk +44 (0)2476 151 057 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.