Active not recruitingOBSERVATIONAL

Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible

This research is exploring a different order of treatments for breast cancer. Normally, radiotherapy is given after surgery, but this study wants to see if starting with a special type of radiotherapy (IMRT) followed by hormone therapy *before* surgery is a good idea. The main goal is to increase the number of women who can have breast-conserving surgery, where only the cancerous lump is removed, rather than the whole breast (mastectomy). This is important because many women are not happy with their appearance after a mastectomy. By potentially shrinking the tumour more effectively before surgery, this new approach aims to make breast-conserving surgery an option for more patients, which could improve their well-being and satisfaction with how they look.

At a glance

Status

Active not recruiting

Sponsor

CCTU- Cancer Theme

Enrolment target

Start

26 Mar 2018

Estimated completion

15 Oct 2026

Breast Cancer

What is this study about?

When someone is diagnosed with breast cancer, treatment plans are carefully considered. Often, surgery is the first step, and for many, this means removing the whole breast (mastectomy). While mastectomy can be a life-saving procedure, a significant number of women are not satisfied with how they look afterwards. Breast-conserving surgery, where only the cancerous lump and a small amount of surrounding tissue are removed, can offer a better cosmetic outcome and improve a woman's overall well-being.

Currently, a type of targeted radiation treatment called Intensity-Modulated Radiotherapy (IMRT) is usually given *after* breast surgery. This study is exploring a new idea: what if we change the order of treatments? The researchers want to see if giving this special radiotherapy *first*, followed by hormone therapy, and *then* surgery, could make breast-conserving surgery possible for more women. The hope is that this sequence of treatments might shrink the tumour more effectively before the operation.

The main aim of this study is to find out if this new treatment order is practical and safe. If successful, it could mean more women have the option of breast-conserving surgery, which could lead to better satisfaction with their appearance and improved quality of life. This research is about finding the best way to help patients achieve both effective cancer treatment and a good quality of life.

Key takeaways

The study explores a new treatment order: targeted radiotherapy, then hormone therapy, then surgery.
The main goal is to help more women have breast-conserving surgery (removing only the lump).
This could improve how women feel about their appearance after treatment.
It's for women with specific hormone-sensitive breast cancer.
Participation involves special radiotherapy, hormone medication, and regular check-ups.

Who may be eligible?

To join this study, you must be a woman aged 18 or older with a specific type of breast cancer that has been confirmed by tests. Your cancer needs to be sensitive to hormones (ER positive) and not have too much of a certain protein (HER2 negative). The lump should be big enough to feel (at least 2cm), and the doctors need to believe that radiotherapy will help make breast-conserving surgery easier for you.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have breast cancer in both breasts. You also can't have the cancer spread to other parts of your body, or have any other serious health issues that would make it difficult to complete the study treatments or attend follow-up appointments.

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 older?
Have you been diagnosed with invasive breast cancer?
Is your cancer hormone-sensitive (ER positive) and HER2 negative?
Is your lump big enough to be felt (2cm or more)?
Have your doctors said that radiotherapy might make breast-conserving surgery easier for you?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have the special radiotherapy treatment, followed by hormone therapy. After these treatments, you would have breast-conserving surgery. The study involves regular visits to the hospital for check-ups, scans, and blood tests to monitor your health and the treatment's effect. You would also need to take hormone medication as prescribed by the study team. The total duration of your active participation, including treatments and follow-up, would be determined by the study protocol, but the team will explain all the appointments and assessments in detail before you decide to join.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as receiving a new treatment approach that may be more effective or lead to a better outcome for you. It also helps others by improving our understanding of how to treat breast cancer. However, there are also potential risks; for example, the new treatment sequence might not work as well for you as standard treatment, or you might experience side effects from the radiotherapy or hormone therapy. You will be given full details of these possible side effects. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom

Common questions

What is breast-conserving surgery?

Breast-conserving surgery means only removing the cancerous lump and a small amount of healthy tissue around it, rather than the whole breast.

What is IMRT?

IMRT is a special type of radiotherapy that precisely targets the cancer, shaping the radiation beam to reduce harm to healthy tissues.

Why change the order of treatments?

Researchers are hoping that giving radiotherapy and hormone therapy *before* surgery will shrink the tumour more, making breast-conserving surgery an option for more women.

Will my treatment be different from standard care?

Yes, in this study, the order of your treatments (radiotherapy first, then hormone therapy, then surgery) is different from the usual approach for this type of cancer.

Will I still get standard treatment if I leave the study?

Yes, if you choose to leave the study at any point, your medical team will ensure you continue to receive appropriate and standard care for your breast cancer.