A trial comparing a drug called ABP 980 (Kanjinti) with trastuzumab (Herceptin) for HER2 positive breast 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 Open a glossary item . 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 Open a glossary item 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 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.