A trial comparing a drug called ABP 980 (Kanjinti) with trastuzumab (Herceptin) for HER2 positive breast cancer

Coronavirus (COVID-19)

We know that this is an especially worrying time for people with cancer and their family and friends. We have separate information about coronavirus and cancer. Please read that information alongside this page. We will update that information as guidance changes.

Read about coronavirus and cancer

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared ABP 980 (Kanjinti) with trastuzumab (Herceptin) in breast cancer that had receptors for the HER2 protein. 

Breast cancer with cells that have a lot of HER2 receptors are HER2 positive. This trial was for HER2 positive breast cancer that had not spread elsewhere in the body (early breast cancer).

This trial was open for women to join between 2013 and 2015. These results were published in 2018. 

More about this trial

We know from research that having trastuzumab along with chemotherapy before and after breast surgery works well for treating some breast cancers. 

Trastuzumab is a targeted cancer drug called a monoclonal antibody. Monoclonal antibodies can seek out cancer cells by looking for particular proteins on the cell’s surface. 

ABP 980 is a new drug called a biosimilar. This means it works in the same way as trastuzumab.

The aim of this trial was to see if ABP 980 worked as well as trastuzumab to treat early stage HER2 positive breast cancer.

Summary of results

The trial team found that ABP 980 worked in a similar way and had similar side effects to trastuzumab. 

About this trial
This was a phase 3 trial. It was a randomised trial. Everyone who took part were put into 1 of 2 treatment groups. Neither they nor their doctor chose which group they were in. 

725 women took part. 

  • 364 women had APB 980 and paclitaxel before surgery 
  • 361 women had trastuzumab and paclitaxel before surgery

Everyone then had surgery to remove their cancer. In the laboratory the pathologists looked at the cancer tissue that was removed to see how well the treatment worked. 

691 women continued with treatment for a year after surgery:

  • 349 continued with APB 980 
  • 171 continued with trastuzumab 
  • 171 changed from trastuzumab before surgery to APB 980 after surgery

Results
After surgery the pathologists looked at the cancer tissue in the laboratory to see how well the treatment worked. They counted samples where there was no sign of cancer. This was considered a complete response. 

The pathologists were able to look at the results of 696 women. They found there was no sign of cancer in the tissue samples of: 

  • 171 women (48%) who had APB 980 before surgery
  • 137 women (41%) who had trastuzumab before surgery

Side effects
When the trial team looked at the side effects they included everyone who had APB 980 and trastuzumab before surgery and after surgery. They looked at the number of women who had bad or very bad side effects.

They also looked at the most common side effects in each group. 

Before surgery
They found it was:

  • 51 women of the 361 (14%) who had trastuzumab
  • 54 women of the 364 (15%) who had APB 980

The most common side effects included:

  • joint pain
  • feeling weak and lack of energy
  • tingling, pain in the feet or hands
  • a drop in the red blood cells and white blood cells 

After surgery
They found that:

  • 11 women of the 171 (6%) continued with trastuzumab
  • 30 women of the 349 (9%) continued with APB 980
  • 13 women of the 171 (8%) changed from having trastuzumab to having APB 980

The most common side effects included:

  • joint pain
  • feeling weak and lack of energy
  • tingling, pain in the feet or hands
  • a drop in the red blood cells and white blood cells 

Conclusion
The trial team concluded that APB 980 and trastuzumab:

  • worked in a similar way
  • gave a similar result
  • had similar side effects

And this was the same for women who changed from having trastuzumab to APB980. This confirmed that there was no problem with switching the treatment. 

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) 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.

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

Dr Karen McAdam

Supported by

Amgen
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11121

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

Rate this page:

Currently rated: 5 out of 5 based on 1 vote
Thank you!
We've recently made some changes to the site, tell us what you think