A study looking at laser therapy for early stage breast cancer (BR-002)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer




Phase 1

This study is looking at a type of laser therapy called Novilase to treat early breast cancer.

If breast cancer has not spread beyond the breast or the lymph nodes Open a glossary item in the armpit on the same side of the body, you usually have surgery to remove it. Depending on the type of surgery you have, you may also have radiotherapy. And you may have other treatments to lower the risk of the cancer coming back.

In this study, researchers are looking at a technique that uses lasers to destroy early breast cancer. They want to find out if this could be a treatment option instead of surgery. They also want to see if it improves the appearance of the breast after cancer treatment and if it helps women recover from treatment more quickly.

Who can enter

You may be able to enter this trial if you

  • Are a woman between the ages of 18 and 80
  • Have been diagnosed with breast cancer after having a needle biopsy
  • Have cancer that be seen clearly on a mammogram or ultrasound scan and on an MRI scan
  • Have a tumour that is no more than 2cm across and is at least 5mm away from your skin and your chest wall
  • Don’t have any other serious medical conditions – the study team can advise you about this

You cannot enter this trial if you

  • Have had cancer in the same breast before
  • Have advanced breast cancer
  • Have a change to a BRCA gene
  • Have a non cancerous (benign Open a glossary item) tumour or ductal carcinoma in situ (DCIS)
  • Have lobular breast cancer, sarcoma of the breast, a rare type of breast cancer called Phyllodes tumour, or Paget’s disease
  • Have breast cancer with more than a quarter of the tumour in between the ducts of the breast, or there is another reason why your cancer can’t be seen clearly on a scan – the study team can advise you about this
  • Have cancer that started somewhere else in your body and has spread to your breast
  • Are already having treatment before surgery for breast cancer (neo adjuvant treatment Open a glossary item)
  • Have problems with your kidneys – the study team can advise you about this
  • Have a pacemaker or any other metal in your body that would mean you can’t have an MRI scan
  • Are taking part in another trial of an experimental drug or treatment
  • Are very overweight (morbidly obese)
  • Can’t lie flat for an hour
  • Are pregnant or breastfeeding

Trial design

The study will recruit up to 60 women. Everybody taking part has laser therapy using the Novilase system, followed by surgery.

It takes 1 to 2 hours to have the laser therapy. You lie on a table and wear goggles to protect your eyes. The doctor will inject some local anaesthetic Open a glossary item into your skin and the breast tissue around the cancer. Then they will make 2 small cuts in your breast to put 2 probes into the tumour. One of these is the laser, the other is a heat probe. When the laser is turned on, a drip of salt water (saline) runs through the probe to cool the tip of the laser as it destroys the cancer. The heat probe continuously monitors the temperature of the laser.

Throughout the procedure, the study doctor will look at an image of your breast on a screen. This is to make sure the laser probe remains in the right place and that the cancer is destroyed.

After the laser therapy, the study team will put a dressing over the cuts. They will place an ice pack on your breast to help reduce any swelling and they will give you painkillers if you need them.

Four weeks later you have more scans, followed by surgery to remove the area where the cancer was.

As part of your standard care, you may have a sentinel lymph node biopsy to check if there are any cancer cells in the lymph nodes Open a glossary item under your arm. If you do have a sentinel lymph node biopsy, you can have this at the same time as your surgery, or you may have a separate operation before or after the laser therapy. The study team will discuss this with you.

The study team will ask how satisfied you are with the appearance of your breast. They will also ask you to fill out a questionnaire about how you are feeling.

Hospital visits

You see the study team and have some tests before having the laser treatment. The tests include

You have the laser therapy as an outpatient. This means you don’t need to stay in hospital overnight.

Within 4 weeks of having laser therapy, you see the study team again and have a physical examination, an ultrasound scan, a mammogram and an MRI scan. They may also ask you to have some blood tests. You then have surgery.

You may also have other treatments such as radiotherapy and hormone therapy. This is standard care and helps to reduce the risk of your cancer coming back. This is not part of the study.

You see the study team for follow up appointments once a year for 5 years.

Side effects

You may feel warmth in your breast during the laser therapy. And you may have some minor scalding of your skin due to the hot saline flowing back up the probe. But the study team will apply a cooling spray or ice to your skin to try to prevent this.

You may have some pain after the treatment and there may be swelling in your breast. This type of swelling usually goes away within a few months.

You have the laser therapy in a sterile environment, but there is a small risk of infection.

There is a possibility that the edge of the cancer may not be destroyed during the laser therapy. If this happens, and the cancer starts growing again, this usually happens within the first year. In this situation, the study doctor would talk to you about the best treatment to have at that time.

Recruitment start:

Recruitment end:

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.

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

Chief Investigator

Michael H. Shere

Supported by

Novian Health

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 11376

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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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