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

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

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This trial is comparing the new drug ABP 980 with trastuzumab (Herceptin) for breast cancer that has receptors for the HER2 protein. If breast cancer cells have a lot of HER2 receptors, the tumour is described as being HER2 positive. This trial is for HER2 positive breast cancer that has not spread elsewhere in the body (early breast cancer).

We know from research that giving trastuzumab along with chemotherapy before and after surgery works well for treating some breast cancers. Trastuzumab is a biological therapy 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 is to see if ABP 980 will work as well as trastuzumab as a treatment for early stage HER2 positive breast cancer.

Who can enter

You may be able to join this trial if all of the following apply.

  • You are a woman who has been diagnosed with HER2 positive breast cancer
  • You are going to have chemotherapy before your surgery
  • Your cancer can be measured
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
  • You have satisfactory blood test results
  • Your liver and kidneys are working normally
  • You are willing to use reliable contraception during treatment and for at least 6 months afterwards if there is any chance you could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have breast cancer in both breasts
  • Have cancer that has spread to other areas of your body
  • Have already had chemotherapy, radiotherapy,  biological therapy or surgery
  • Are having an experimental drug or have had an experimental drug in the last 4 weeks
  • Are known to be allergic or very sensitive to trastuzumab (Herceptin), ABP 980 or to the chemotherapy drugs cyclophosphamide, epirubicin or paclitaxel (or any similar drugs)
  • Have nerve damage causing numbness or tingling in your hands or feet (peripheral neuropathy)
  • Need to take medicine to control heart pain (angina)
  • Have any other heart problems or high blood pressure that is not well controlled (your doctors can advise you about this)
  • Are breathless and need to have oxygen
  • Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • Have an infection in the 2 weeks before starting treatment which needs antibiotics
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Have another serious medical condition or mental health problem that the trial team think could affect your taking part
  • Are pregnant or breastfeeding

 

Trial design

This phase 3 trial is an international study. In total the researchers will need about 808 women to take part.

Before having surgery for their breast cancer, everyone taking part in the trial will have the chemotherapy drugs epirubicin and cyclophosphamide every 3 weeks. Each 3 week period is called a cycle of treatment. You will have up to 4 cycles, lasting about 3 months in total.

People taking part are then put into 2 treatment groups by a computer. This is called randomisation. Neither you nor your doctor will be able to decide which group you are in.  And neither of you will know which group you are in. This is called a double blind trial.

  • One group will have ABP 980 and paclitaxel (Taxol) every 3 weeks for 4 cycles or once a week for 12 cycles
  • One group will have trastuzumab (Herceptin) and paclitaxel every 3 weeks for 4 cycles or once a week for 12 cycles

11121 Trial Diagram

Your doctor will be able to decide how often you have the drugs but they won’t know which drugs you are having. You will have this treatment for about 3 months in total.

After you finish this treatment you will have surgery to remove your breast cancer.

After surgery, you have more treatment as part of the trial. What you have depends on which group you were in before your operation.

If you were in the group having ABP 980 before your surgery, you will have this drug again. You have it every 3 weeks for up to a year from when you first started having it.

If you were in the group having trastuzumab before your surgery, you will be put into one of 2 groups at random.

  • One group will have ABP 980 every 3 weeks for up to a year from when they first started having trastuzumab
  • One group will have trastuzumab for up to a year from when they first started having it

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • Heart trace (ECG)
  • Heart scan (echocardiogram) or MUGA scan

You have regular blood tests and physical examinations during your treatment. You also have repeats of either the echocardiogram or MUGA scan.

After about 6 months of treatment, you have your surgery. Your treatment will start again up to 6 weeks after surgery.

You visit the hospital up to 23 times during this trial.

After you finish treatment you have another physical examination, blood tests and an echocardiogram or MUGA scan.

Side effects

The most common side effects for trastuzumab (Herceptin) and ABP 980 are

The most common side effects of cyclophosphamide are

The most common side effects of epirubicin are

  • An increased risk of getting an infection from a drop in white blood cells
  • Tiredness and breathlessness due to a drop in red blood cells (anaemia)
  • Hair loss occurs in everyone who has epirubicin and includes all head and body hair
  • Your urine may become a pink or red colour for about one day after treatment

The most common side effects for paclitaxel (Taxol) are

  • Weakness
  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Low blood pressure
  • Joint and muscle pain
  • Hair loss
  • Feeling or being sick
  • A sore mouth
  • A mild allergic reaction including flushing and skin rash
  • Numbness or tingling in fingers and toes

We have more information on the side effects of

 

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:

Oracle 11121

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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