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

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This trial looked at a type of laser therapy called Novilase to treat early breast cancer that had not spread.

More about this trial

Doctors usually treat breast cancer that has not spread with surgery. They sometimes also use radiotherapy and other treatments such as hormone therapy. These all help reduce the risk of the cancer coming back.

In this trial, researchers looked at a technique called laser ablation to kill breast cancer cells. It was for people with early stage breast cancer. The research team hope that laser treatment could be a good alternative to surgery.

The aims of this trial were to see:

if laser ablation could be a useful treatment for early breast cancer
how laser ablation affects the appearance of the breast
how quickly people recover after treatment

Summary of results

The research team found that laser treatment may be a good treatment option for early stage breast cancer in the future.

This trial was open for people to join between 2012 and 2015, and the team published the results in 2018.

About this trial
Everyone in this trial had a single area of breast cancer that measured 2cm or less. They had not had any treatment for their breast cancer.

As part of the trial they had:

an ultrasound scan, an MRI scan and a mammogram before treatment
laser treatment
another ultrasound, MRI scan and mammogram 4 weeks later
an operation to check for, and remove, any signs of breast cancer

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The doctor put a small probe with a laser fibre through the skin and into the area of cancer. They used ultrasound to make sure the probe was in the right place.

Next they placed a second probe through the skin near the laser probe. This one had several temperature sensors on it and was used to monitor how the treatment was going.

They then heated the end of the laser fibre until the cancer cells at the edge of the area being treated reached a high enough temperature to kill them. This is either 60 degrees Celsius, or 51 degrees Celsius for at least 2 minutes.

Results
61 people joined this trial and they all had laser treatment and then an operation 4 weeks later. The laser treatment took between 14 and 36 minutes.

The research team looked at the results for everyone taking part. They showed that 51 out of 61 people (84%) had no signs of cancer after laser treatment.

They then looked at people who had a smaller area of cancer to begin with (1.5cm or less). They found there was no sign of cancer in 46 out of 47 people (98%).

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As part of this trial, the team looked at how accurate MRI scans were at showing whether there were still cancer cells present after laser treatment. They compared MRI results to what they found when they analysed the cells in the laboratory after the operation (pathology).

The doctors found the MRI results were the same as the results from laboratory analysis after surgery for 52 people (87%). But they were different in 8 people (13%) - a false positive or a false negative result. One person didn’t have an MRI scan after laser treatment.

47 people had no signs of cancer on their MRI or on laboratory analysis
5 people had signs of cancer on their MRI and on laboratory analysis
4 people had signs of cancer on their MRI but not on laboratory analysis
4 people had no signs cancer on their MRI but did on laboratory analysis

Quality of life
The people taking part filled out quality of life questionnaires before and after they had laser treatment. The questionnaires asked them about things such as pain, satisfaction with the treatment and how their breast looked after treatment (the cosmetic result).

The results showed that:

most people (97%) were satisfied with the treatment and the cosmetic result 4 weeks afterwards
the average maximum level of pain during laser treatment was 4.2 out of 10
nearly 8 out of 10 people (78%) were able to return to their usual day to day activities straight away
people’s quality of life scores were better than for some other breast cancer treatments
people had less fatigue, pain and insomnia than those who’d had surgery to remove a breast lump (a lumpectomy)

Side effects
No one taking part had any severe side effects. A small number of people had short term side effects such as mild pain, bruising or a lump or blister where they’d had laser treatment.

Conclusion
The research team concluded that laser ablation treatment could be a possible alternative to surgery for early stage breast cancer. They suggest more trials are done to find out more about it.

They recommend doing a trial where people don’t automatically go on to have surgery afterwards. This would give more information about how well laser treatment works long term.

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.