A study looking at changing the order you have treatment for breast cancer (Neo-RT)

Cancer type:

Breast cancer

Status:

Open

Phase:

Other

This study is looking at giving radiotherapy and then starting hormone therapy before having surgery to remove breast cancer.

This study is open to women with breast cancer that:

has receptors for the hormone oestrogen (ER positive) and
doesn’t have receptors for the protein HER2 (HER2 negative)

More about this trial

Doctors treat ER positive and HER2 negative breast cancer with surgery followed by radiotherapy and then hormone therapy.

Researchers think that having radiotherapy then hormone therapy before surgery might be better. As this could shrink the cancer and so the surgeon might be able to save more of the breast.

To find out whether it is better they need to do a clinical trial. Before doing a clinical trial they need to know that changing the order of treatment is possible and acceptable. This is a feasibility study.

The aims of this feasibility study are to see if:

it is possible to change the order of treatment
changing the order of treatment helps shrink the cancer, which would reduce the amount of surgery women need and so save more of the breast

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if you are a woman and the all of the following apply:

you have invasive breast cancer that has receptors for the hormone oestrogen (ER positive) and does not have receptors for HER2 (HER2 negative)
you are able to have breast conserving surgery
your cancer measures 20mm or more and the doctor can feel the lump
your cancer is slow growing (grade 1) or intermediate (grade 2), you might be able to take part if your cancer is fast growing (grade 3) and you are not suitable to have chemotherapy before surgery
your doctor thinks that radiotherapy might make it easier for you to have breast conserving surgery
you are up and about for at least half the day and can look after yourself (performance status 0, 1 or 2)
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have cancer in both breasts
have cancer that has spread to another part of the body (metastatic)
have cancer in 2 or more areas of the breast and you cannot have breast conserving surgery
are not able to have radiotherapy
are not able to take hormone therapy after surgery
have had another cancer in the past 5 years unless it was successfully treated and there hasn’t been any sign of it since
have another medical or mental health condition that the doctor or study team think could affect you taking part
are pregnant
are breastfeeding

Trial design

This is a feasibility study. The team need 43 women to join. You have treatment in this order:

radiotherapy
hormone therapy
surgery

You have radiotherapy either:

once a day Monday to Friday for 3 weeks or
once a week for 5 weeks or
once a day for 5 days

You have a radiotherapy planning session before starting radiotherapy. This is to plan where the radiographers need to give the radiotherapy. It is just like having radiotherapy without having the treatment.

You start hormone therapy the day after your last radiotherapy treatment. You take it for 20 weeks before surgery.

This will be either letrozole or tamoxifen. These are tablets. Your doctor will tell how many you need to take.

Women who haven’t gone through the menopause (premenopausal women) might have another drug called a gonadotropin-releasing hormone agonist (GnRH) with tamoxifen.

You then have surgery to remove the cancer.

NEO-RT flow chart diagram

Quality of life
You fill in a questionnaire before starting treatment and then:

before your surgery
6 months after surgery
every year for 5 years

The questions ask about:

your general health
any side effects or complications from treatment
your daily activities

This is a quality of life questionnaire.

Research scans
The trial team will ask you to have a research MRI scan:

before starting treatment
at the start of your radiotherapy
at the end of your radiotherapy
after starting hormone therapy
before having surgery

This research MRI scan is the same as an MRI scan but it takes longer to do. The research MRI scan takes an hour. You don’t have to agree to have these scans. You can still take part in the main study.

The team will ask women from Cambridge to have a research scan called multi spectral optoacoustic tomography (MSOT). This scan uses pulses of light to look at the breast tissue. You have the scan:

before starting treatment
at the start of radiotherapy
at the end of radiotherapy
after starting hormone treatment
before having surgery
then every year during follow up when you have your mammogram

The scan takes about 10 to 15 minutes. You don’t have to agree to have these scans. You can still take part in the main study.

Tissue and blood samples
The team will also ask permission to take some cancer tissue samples (biopsies) and blood sample during the study. You don’t have to agree to these. You can still take part in the main study.

Hospital visits

You see the doctor to have tests before taking part. These tests include:

physical examination
planning CT scan
an MRI scan or ultrasound or the research MRI scan and the multi spectral optoacoustic tompgraphy (MSOT) research scan if you agreed to this

You have the scans again when you start hormone treatment and before surgery.

You see the doctor within a month after your surgery and then at:

3 months
6 months
then once a year for 5 years

Side effects

The treatments are all standard treatments. You doctor will talk to you about the side effects.

We have information on the side effects of:

Location

Cambridge

London

Recruitment start:

04/12/2017

Recruitment end:

30/07/2021

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Charlotte Coles

Supported by

Breast Cancer Now
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge

Freephone 0808 800 4040

Email

Last review date

5 February 2021

CRUK internal database number:

16361