
“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."
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 . 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.
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.
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.
Everyone then had surgery to remove their cancer. In the laboratory the 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:
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:
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:
The most common side effects included:
After surgery
They found that:
The most common side effects included:
Conclusion
The trial team concluded that APB 980 and trastuzumab:
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 () 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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Karen McAdam
Amgen
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“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."