A trial looking at atezolizumab and chemotherapy for triple negative 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 for people with triple negative breast cancer who are going to have treatment for the first time. Triple negative breast cancers are cancers whose cells don’t have receptors for:

the hormones oestrogen and progesterone
the Her 2 protein

More about this trial

For triple negative breast cancer, you usually have a combination of chemotherapy drugs followed by surgery. Chemotherapy before surgery is called neoadjuvant therapy. It can shrink the cancer and make surgery more successful.

In this trial, researchers are looking at whether adding a drug called atezolizumab to chemotherapy improves the neoadjuvant therapy.

Atezolizumab (Tecentriq) is a type of immunotherapy. It works by blocking a protein that stops the immune system from working properly and attacking cancer cells.

Everyone taking part in this trial has one of the following neoadjuvant treatments:

atezolizumab and chemotherapy
dummy drug (placebo) and chemotherapy

The chemotherapy drugs you have in this trial are:

The main aim of this trial is to find out how well atezolizumab and chemotherapy work as a neoadjuvant treatment for triple negative breast cancer.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

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

you have a newly diagnosed triple negative breast cancer and haven’t had any treatment for it
your cancer measures at least 2 cm across (T2, T3 or T4) and there is no sign that the cancer has spread to other distant parts of the body
you are willing to have surgery after neoadjuvant therapy
your heart is working well
you have satisfactory blood test results
you have a sample of tissue available that can be used to look for a protein called PD-L1 and to confirm your diagnosis of triple negative breast cancer
you are able to do everything apart from heavy physical work (performance status 0 or 1)
you are willing to use reliable contraception during treatment and for up to a year afterwards if there is any possibility that you or your partner could become pregnant
you are at least 18 years old

Who can’t take part

Cancer related

You cannot join this trial if any of these apply:

you have had a previous invasive breast cancer
you have breast cancer in both breasts (bilateral)
your cancer has spread to other distant parts of the body (metastatic)
you have had treatment for breast cancer that reached your whole body (systemic)
you have had atezolizumab, doxorubicin, paclitaxel or any other similar drug
you have had ductal carcinoma in situ (DCIS) unless you have had surgery to remove the breast (mastectomy) more than 5 years ago
you have had pleomorphic lobular carcinoma in situ (LCIS) unless you have had surgery for it more than 5 years ago
you have had an operation to remove the tumour, or a piece of tumour, where the cancer first started (excision or incisional biopsy)
you have had an operation to remove all the lymph nodes from the armpit or to remove the sentinel lymph node involved with cancer
you have had another cancer in the last 5 years part from non melanoma skin cancer, an early cancer of the womb, localised prostate cancer, or carcinoma in situ of the cervix that has been successfully treated

Medical conditions

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

have had a stroke in the last 12 months
have heart problems such as an irregular heart rhythm (arrhythmia), high blood pressure or angina that isn’t controlled, moderate or severe congestive heart disease, or you have had a heart attack in the last year
have, or have had, an active autoimmune disease unless it is type 1 diabetes, a thyroid problem called hypothyroidism, or a skin condition called psoriasis, vitiligo or eczema that is stable
have or have had lung problems such as pneumonitis
take or have taken drugs that damp down (supress) your immune system such as steroids in the past 2 weeks, unless it was a very small dose or an inhaler
take or have taken drugs that stimulate the immune system such as interferon in the past 4 weeks
have HIV
have hepatitis B or hepatitis C
have active tuberculosis
have, or have had a severe infection in the last month
have taken antibiotics in the last 2 weeks
have had a major surgery in the last 4 weeks, or doctors think that you will need to have an operation during this trial
have had an organ transplant from a donor
have any other medical condition that the trial team think could affect you taking part

Other

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

you are sensitive to any of the drugs used in this trial or anything they contain
have had a live vaccine in the last month
are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. Researchers hope that up to 324 people worldwide and 9 people from the UK will agree to take part.

It is a randomised trial. Everyone taking part is put into 1 of the following groups by computer:

atezolizumab and chemotherapy
dummy drug and chemotherapy

Neither you nor your doctor are able to choose which group you are in and neither you nor your doctor will know which group you are in. This is called a double blind trial.

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Atezolizumab or dummy drug

You have atezolizumab or dummy drug as a drip into your bloodstream (intravenously) every 2 weeks. It takes between 30 minutes and 60 minutes to have atezolizumab or dummy drug each time.

You can have up to 10 treatments with atezolizumab or dummy drug, taking about 4 and a half months.

Chemotherapy

Everyone has the following chemotherapy drugs:

nab-paclitaxel
doxorubicin
cyclophosphamide

First, you have nab-paclitaxel as a drip into your bloodstream every week for 12 weeks. You have it at the same time you have atezolizumab or dummy drug.

After 12 weeks (about 3 months), you stop nab-paclitaxel. You then have:

doxorubicin as a drip into your bloodstream every 2 weeks
cyclophosphamide as a drip into your bloodstream every 2 weeks

You have up to 4 doxorubicin and 4 cyclophosphamide treatments, taking about 2 months in total.

Breast cancer surgery

After you finish chemotherapy, you have breast cancer surgery. This is the same as the standard treatment. Your doctor can tell you more about this.

After surgery, you and your doctor will find out whether you have had atezolizumab or dummy drug.

If you had atezolizumab, you might be able to continue to have atezolizumab after surgery. You have it every 3 weeks, for up to 11 treatments (about 8 months).

If you had dummy drug, your doctor will follow you up closely after surgery. You see the doctor every 3 weeks, for up to 11 visits. This is called monitoring.

After the operation, you may also have radiotherapy and chemotherapy. You have chemotherapy if doctors find cancer cells in your breast or armpit during surgery. Your doctor can tell you more about this. This is the same as the standard treatment.

Tissue sample

The trial team will ask to use a tissue sample of your cancer taken when you had a biopsy. They might also ask you to give a new tissue sample:

3 weeks after the start of treatment
during breast cancer surgery
if your cancer comes back

You don’t need to agree to give a tissue sample 3 weeks after the start of treatment if you don’t want to. You can still take part in this trial.

Blood tests

You have extra blood tests as part of this trial. You have them before the start of treatment and then:

at set times during the trial
within a month after finishing treatment with atezolizumab or monitoring

Researchers want to:

find out what happens to the drugs inside your body (pharmacokinetics)
look for certain proteins (biomarkers) that can help to tell how well the treatment is working
look at the cancer DNA

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

a physical examination
heart trace (ECG)
a heart scan (MUGA or ECHO)
blood tests
urine test
breast ultrasound
a lung function test
a mammogram

During treatment, you see the trial team regularly. You have blood tests and a physical examination each time you see them. You also have a heart scan at set times during this trial.

You have an ultrasound before surgery and a mammogram every year. You might also have other scans such as:

• MRI scan

• CT scan or PET-CT scan

• bone scan

This is the same as the standard treatment. Your doctor can tell you more about this.

When you finish treatment or monitoring, you see the trial team every 3 months, for up to 3 years. You then see the trial team every 6 months until the end of this trial. You might have a physical examination and scans every time you see them. You may also complete some questionnaires at set times.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment.

Atezolizumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. Side effects can happen during treatment or some months after treatment has finished. In some people, these side effects can be life threatening.

The most common side effects of atezolizumab are: