A trial looking at trastuzumab emtansine and pertuzumab for breast cancer (KAITLIN)

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 looking at drug called trastuzumab emtansine alongside pertuzumab for breast cancer. The trial is for people whose breast cancer has a large number of HER2 receptors (it is HER2 positive).

Doctors can treat breast cancer with surgery. After surgery if your breast cancer is HER2 positive you will have a biological therapy called trastuzumab (Herceptin). Trastuzumab works by seeking out cancer cells that have a particular protein. You may also have a taxane chemotherapy drug Open a glossary item with trastuzumab.

Pertuzumab is another type of biological therapy. It too looks for a particular protein on the cancer cell but works in a slightly different way to trastuzumab.

Trastuzumab emtansine (pronounced trast-oo-zoo-mab em-tan-seen) is a combination of trastuzumab and the chemotherapy drug emtansine. The trastuzumab finds the cancer cells and delivers the emtansine chemotherapy to them. This type of drug is called a conjugated monoclonal antibody.

In this trial the researchers want to compare

Trastuzumab emtansine alongside pertuzumab
Trastuzumab and pertuzumab alongside a taxane chemotherapy drug

They want to find out which is best to stop HER2 positive breast cancer coming back after surgery. They also want out find out more about the side effects of the drugs in this trial.

Who can enter

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

You have breast cancer that has a large number of HER2 receptors (is HER2 positive )
You have had surgery to remove your cancer
Your cancer has been tested for hormone receptors
You have had a sentinel lymph node biopsy or lymph nodes under your arm removed
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Your heart works well enough (your doctor will do a test to find this out)
You have recently been tested for hepatitis B and hepatitis C (if you haven’t your doctor will do the test)
You have satisfactory blood test results
You are willing to use 2 reliable forms of contraception during treatment and for 7 months afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

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

Have breast cancer that has spread to your chest wall or skin (stage T4)
Have cancer that has spread to another part of your body
Have inflammatory breast cancer
Have cancer in both of your breasts unless both cancers have a large number of HER2 receptors
Have had a previous breast cancer
Had breast cancer surgery more than 9 weeks ago
Have had, or are having, any other anti cancer treatment apart from surgery
Can’t have radiotherapy
Have had another cancer in the past 5 years apart from non melanoma skin cancer and some early stage cancers
Have certain heart problems (the trial team can advise about this)
Are known to have HIV
Have any other medical condition that could affect you taking part in this trial
Are taking medication that dampens down your immune system
Are sensitive to the drugs, or their ingredients, used in this trial
Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need 2,500 people to join.

To start with everyone has an anthracycline chemotherapy drug Open a glossary item . You have it every 3 weeks. Each 3 week period is called a cycle of treatment. You have 3 or 4 cycles of treatment. You have the anthracycline chemotherapy as an injection into a vein.

You are then put into a treatment group by a computer. This is called randomisation. Neither you nor your doctor will be able to decide which group you are in.

People in group 1 have trastuzumab, pertuzumab and a taxane drug
People in group 2 have trastuzumab emtansine and pertuzumab

11814 Trial Diagram

You have all these drugs as an injection into a vein. You have them every 3 weeks. You can have up to 18 cycles of treatment as long as it helping you and the side effects aren’t too bad.

The trial team will ask you to fill out a questionnaire before you start treatment, every 3 weeks for 3 months, then every 2 months during treatment and at 6 months and 1 year after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery. You must agree to this if you want to take part in the trial.

They will also ask for extra blood samples to look for substances (biomarkers Open a glossary item ) that may help measure how well the treatment is working and to find out more about breast cancer. You don’t have to agree to this. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These tests include

A physical examination
Blood tests
Heart trace (ECG )
Heart scan (ECHO or MUGA )
Mammogram (if needed)
Chest X-ray

During treatment you see the doctor every 3 weeks for a physical examination and blood tests. You have a heart scan every 3 months.

Three weeks after finishing treatment you see the doctor for

A physical examination
Blood tests
Heart Trace
Heart scan

After treatment you see the doctor for a physical examination and blood tests every 3 months for 2 years. After this you have a physical examination every 6 months for another 3 years and then every year for another 5 years.

You have a mammogram every year. You have regular heart scans for 5 years.

Side effects

The most common side effects of trastuzumab emtansine include

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Difficulty getting to sleep
Nose bleed
Sore, dry mouth
Shortness of breath
Changes to the way your liver works
Rash, reddening of the skin
Feeling or being sick
Constipation or diarrhoea
Tummy (abdominal) pain
Tingling, pain, numbness, itching, pins and needles in your hands or feet
Painful joints or muscles
Tiredness
Weakness
High temperature (fever)
Chills
Headache
Urine infection
Sore watery eyes
Loss of appetite and taste changes
Heartburn and indigestion

The most common side effects of trastuzumab include

Dizziness
Difficulty getting to sleep
Head cold
Runny nose
Nose bleed
Cough and flu like symptoms
Sore mouth
A drop in blood cells causing an increased risk of infection, bleeding and bruising
Shortness of breath
Rash, reddening of the skin
Cracked nails
Hair loss
Tingling, pain, numbness, itching, pins and needles in your hands or feet
Build up of fluid in your arms or legs causing swelling
Loss of appetite and taste changes
Heartburn and indigestion
Painful joints, muscles, chest, throat and tummy (abdomen)
Tiredness
Weakness