HER2-RADiCAL

HER2-RADiCAL is investigating whether some people with HER2 positive breast cancer can safely receive less treatment after surgery.

Status: Enrolling participants

What is the study about?

HER2-RADiCAL is investigating whether some people with HER2 positive breast cancer can safely receive less treatment after surgery.

HER2 is a protein which can cause cancer to grow. If breast cancer has higher than normal levels of HER2 it is classified as HER2 positive. People with this type of breast cancer normally receive chemotherapy as well as targeted treatments, called trastuzumab and pertuzumab, which block the effects of HER2. These treatments are given before and after people have surgery to remove their cancer. After surgery trastuzumab is usually taken for 12 months, and further chemotherapy and pertuzumab may also be given.

People with HER2 positive breast cancer have a very good chance of remaining free of their cancer after treatment if there are no cancer cells in the tissue removed during surgery. This means it is possible to reduce the treatment given after surgery. This will reduce the possible side effects and disadvantages of a longer course of treatment, whilst not increasing the risk of cancer returning.

HER2-RADiCAL will investigate whether people with HER2 positive breast cancer can receive less trastuzumab treatment, and stop taking pertuzumab and chemotherapy if there is no cancer found in their surgical samples. The results of HER2-RADiCAL will allow us to find out if a more personalised treatment plan can be offered to patients with HER2 positive breast cancer in the future.

Who is included in the study?

HER2-RADiCAL includes people with HER2 positive breast cancer which has not spread to other parts of the body. Participants will have had treatment with chemotherapy, trastuzumab and pertuzumab before surgery to remove their cancer. Only people whose surgical samples did not contain any cancer cells will be able to join HER2-RADiCAL. Up to 720 people will be included from NHS hospitals across the UK.

What are the study treatments?

All HER2-RADiCAL participants will continue to take trastuzumab for a total of six months. Participants will not receive any further chemotherapy or pertuzumab after joining the study.

Participants have regular check ups during and after their treatment and we will collect information about how they are getting on until the study is completed. Participants will be closely monitored for any signs that their cancer has returned. If this happens, they will receive further treatment as needed, which will be decided between them and their local hospital doctors.

Sub‑study

The study team would like to understand why people choose to take part in the main study or decide not to. They are looking for around 10 to 20 people to take part in this study within a trial (SWAT).

A member of the study team will invite you to take part when they discuss the main study with you, or shortly afterwards.

If you decide to take part, you will be asked to complete a questionnaire. This can be completed online. If you prefer, the questionnaire can be posted to you and returned using the stamped addressed envelope provided.

You can take part in this sub‑study without joining the main study. Likewise, if you choose to take part in the main study, you do not have to take part in this sub‑study.