“I had treatment last year and I want to give something back.”
A trial looking at the effect of having trastuzumab or lapatinib before surgery on early breast cancer (EPHOS B)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing the affects of trastuzumab (Herceptin) and lapatinib (Tyverb) with trastuzumab on breast cancer cells before having surgery. This trial is for people whose breast cancer has tested positive for the HER2 protein. This is called HER2 positive breast cancer. This trial is supported by Cancer Research UK.
Doctors often treat HER2 positive breast cancer with surgery, followed by chemotherapy and then Herceptin. We know from research that 1 year of Herceptin after surgery lowers the risk of the cancer coming back in people with HER2 positive breast cancer.
The researchers think that having drugs that work by blocking the HER2 protein before surgery may lower the risk more. This trial will study the effects of blocking the HER2 protein in cancer cells before surgery. People may have one of two HER2 blocking drugs as a part of this trial
- Herceptin which is a monoclonal antibody. It works by targeting and blocking the HER2 protein
- Lapatinib which is a type of biological therapy called a tyrosine kinase inhibitor (TKI)
Tyrosine kinases are proteins that stimulate cancer cells to grow. One of the proteins that lapatinib blocks is the HER2 protein.
The aims of this study are to
- Look for changes in HER2 positive breast cancer cells after having Herceptin or lapatinib for a short time before surgery
- Compare the effects of having Herceptin and lapatinib before surgery in breast cancer cells
Who can enter
You can enter this trial if
- You have breast cancer that is HER2 positive
- Your cancer has grown into the surrounding breast tissue
- You are planned to have surgery to remove your breast cancer within the next month
- You are able and willing to have chemotherapy and Herceptin after your breast surgery
- Your kidneys work well enough – your doctor will test for this
- You are up and about for at least half the day and able to look after yourself (performance status 0, 1, 2 or Karnofsky 60 and over)
- You are willing to use reliable contraception if there is a chance you could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have breast cancer that has tested negative for the protein HER2 or has not been tested
- Have breast cancer that cannot be removed with surgery or have inflammatory breast cancer (stage T4)
- Have breast cancer that has, or may have, spread to another part of your body
- Have had Herceptin in the last 12 months
- Have had radiotherapy to your breast
- Are not able to have chemotherapy or Herceptin after your surgery
- Have had treatment for another cancer in the last 6 months apart from basal cell carcinoma or carcinoma in situ of the cervix
- Have problems with your liver
- Have problems with digestion that may affect how you absorb tablets
- Have had serious heart problems
- Have high blood pressure that is not controlled
- Have another serious medical condition that could affect you taking part in this trial
- Are known to be sensitive to other drugs that are similar to Herceptin or lapatinib – your doctor can advise about this
- Are taking other medication to treat cancer or as part of a clinical trial
- Are not willing to stop taking herbal medicines
- Are taking steroid tablets (you should not stop taking your steroids unless your doctor tells you to)
- Are taking certain medications that could interfere with the trial medication – your doctor can advise about this
This is a phase 3 trial. It will recruit about 250 people. It is a randomised trial. The people taking part are put into one of 3 treatment groups. Neither you nor your doctor can choose which group you are in.
Everyone taking part in this trial will have chemotherapy and Herceptin after surgery which is part of standard practice.
If you are in group 1, you have surgery followed by chemotherapy.
If you are in group 2, you have 2 doses of Herceptin (one week apart) before surgery. After surgery you have another dose of Herceptin before starting chemotherapy.
If you are in group 3, you have about 11 days of lapatinib and 2 doses of Herceptin (one week apart) before surgery. After surgery, you continue taking lapatinib for about another 17 days and have another dose of Herceptin, before starting chemotherapy. The medical team will tell you when to start and stop taking lapatinib.
Everyone has surgery about 2 weeks after being put into their treatment group.
You have Herceptin through a drip into a vein. You have the first dose over about 90 minutes and need to stay at the hospital for about 4 to 6 hours afterwards. This is to make sure you don’t have a reaction to the Herceptin. The rest of the doses will take about 30 minutes and your doctor will tell you how long you need to stay at the hospital each time.
Lapatinib are tablets you take at home. You take 4 tablets at the same time each day. This should be early evening, at least 1 hour before or after a meal. You should not take medicines for indigestion (antacids) for 1 hour before or after taking your lapatinib tablets.
If you take part in this trial the researchers will ask your permission to take some tissue samples from when you had your biopsy and from your surgery. They will also ask for some extra blood samples. These will be taken when you agree to take part in the trial, at surgery and about 1 month later. The researchers will use these samples to look at the changes in your breast cancer.
You will see the doctor and have some tests before you start treatment. These tests include
- A physical examination
- Blood tests
- X-ray or CT scan of the chest
- Heart trace (
- Heart scan (
- Pregnancy test (if appropriate)
After surgery you have a heart trace and a heart scan before starting chemotherapy. You then see the doctor at
- 1 month
- 6 months
- Every 6 months, up to 2 years
- Every year, up to 10 years
The side effects of Herceptin can include
- Fever and chills
- Feeling, or being, sick
- Shortness of breath
- Low blood pressure
- Fast heart rate
- An allergic reaction
The side effects of lapatinib can include
While taking lapatinib you should not eat grapefruit or drink grapefruit juice because it can interfere in the way lapatinib works.
How to join a clinical trial
Prof Nigel Bundred
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester (UHSM)
University of Manchester
This is Cancer Research UK trial number CRUK/08/002.