A trial of a chemotherapy drug called nab-paclitaxel alongside gemcitabine or carboplatin for triple negative breast cancer that has spread (tnAcity)

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 2/3

This trial is looking at a drug called nab-paclitaxel with either gemcitabine or carboplatin for triple negative breast cancer. If breast cancer doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2, it is called triple negative breast cancer

Doctors usually treat breast cancer with surgery. You may also have other treatments such as chemotherapy to try to stop the cancer coming back in the breast or spreading to another part of your body.

But sometimes breast cancer does spread somewhere else in the body. This is called secondary or metastatic breast cancer.

Some of the treatments that doctors can use to treat metastatic breast cancer, such as hormone therapy or a drug called Herceptin don’t work for triple negative breast cancer. So if this type of cancer spreads somewhere else in the body, you are most likely to have chemotherapy. The chemotherapy drugs that doctors may use include gemcitabine, carboplatin and paclitaxel (also known as Taxol).

One type of paclitaxel is combined with a protein called albumin to form a drug called nab-paclitaxel (also known as Abraxane). This form of the drug can be given at a higher dose and it may work differently to Taxol.

In this trial, researchers are looking at nab-paclitaxel alongside either gemcitabine or carboplatin. They are comparing these drug combinations with a combination of gemcitabine and carboplatin. The women taking part have not had any other treatment for breast cancer that has spread, so doctors call this first line treatment Open a glossary item .

The aims of the trial are to

See which drug combination works best as first line treatment for triple negative breast cancer that has spread
Learn more about the side effects

Who can enter

You may be able to enter this trial if you

Are a woman with breast cancer that has spread to another part of your body (metastatic breast cancer)
Have breast cancer that doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2 (triple negative breast cancer)
Had chemotherapy before or after breast cancer surgery to try to stop the cancer coming back, this finished at least 6 months ago, scans show that your cancer has got worse since then and the treatment included a drug called an anthracycline (unless you couldn't have an anthracycline for some reason, or it wasn't the best treatment option for you). If your chemotherapy included a taxane drug , gemcitabine, or a platinum drug , it must have finished at least a year ago
Have areas of cancer spread that can be measured on a scan (if you’ve already had radiotherapy to the area, the scans must show that the cancer has got worse since)
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use 2 types of reliable contraception during the trial and for 4 weeks afterwards if there is any chance you could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain or to the layers of tissue covering your brain
Have breast cancer that has spread only to your bones, or only to lymph nodes close to the cancer
Have already had chemotherapy for breast cancer that has spread or for breast cancer that had come back and could not be completely removed with surgery
Have had major surgery in the last month or haven’t fully recovered from earlier surgery
Are currently having any other cancer treatment
Haven't completely recovered from any side effects of radiotherapy
Haven’t recovered from side effects of any other cancer treatment, unless they are very mild
Are taking part in another clinical trial or have had another experimental treatment in the last 4 weeks
Have nerve damage from earlier treatment (peripheral neuropathy) unless it is quite mild
Have had a heart attack in the last 6 months or have certain other heart or lung problems (the trial team can advise you about this)
Have any other serious medical condition, mental health problem or allergies that the trial team think could affect your taking part
Have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
Are known to be very sensitive to nab-paclitaxel, gemcitabine, carboplatin or any similar drugs
Are HIV positive, or take any medication that damps down your immune system and increases your risk of infections
Are pregnant or breastfeeding

Trial design

This is an international trial that will recruit nearly 800 women in a number of different countries. The trial is in 2 parts.

The 1st part of the trial will recruit about 240 women. The aim of this part is to find which of the drug combinations containing nab-paclitaxel is best. It is a randomised trial. The women taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part has 3 week cycles of treatment. You have 2 drugs through a drip into a vein in the 1st and 2nd week of each cycle. The 3 different treatments are

Nab-paclitaxel and gemcitabine
Nab-paclitaxel and carboplatin
Gemcitabine and carboplatin

The 2nd part of the trial will recruit about 550 women. The aim of this part is to look at the best drug combination containing nab-paclitaxel that the researchers found in the 1st part of the trial and compare it with the combination of gemcitabine and carboplatin. This part of the trial is also randomised, but the women will be put into 1 of 2 groups. Depending on results from the 1st part of the trial, you have 1 of the following

Either nab-paclitaxel and gemcitabine or nab-paclitaxel and carboplatin
Gemcitabine and carboplatin

As long as you don’t have bad side effects, and you don’t need to have surgery or radiotherapy, you can carry on having treatment for as long as both you and your doctor think it is helping you.

If you join the 2nd part of the trial, the trial team will ask you to fill out a questionnaire before you start treatment, every 3 weeks during treatment and 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.

Hospital visits

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

Physical examination
Blood tests
CT scan or MRI scan
Heart trace (ECG )
Bone scan

During the trial, you go to hospital twice in each 3 week cycle of treatment. You have regular blood tests. You have a CT scan every 6 weeks. You may need to have more bone scans.

When you finish treatment, you see the trial team again about 4 weeks later. After that a member of the team will contact you by phone every 3 months to see how you are and whether you have started any other treatment.

If you stop the trial treatment for any reason other than your cancer getting worse, the trial team will ask you to carry on having scans every 6 weeks unless your cancer does start to get worse.

Side effects

The most common side effects of nab-paclitaxel include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Constipation
Diarrhoea
Sore mouth
Feeling or being sick
Weakness or tiredness (fatigue)
Pain in your muscles or joints
Chest pain
Swelling caused by a build up of fluid in your ankles, feet, toes or fingers
High temperature (fever)
Loss of appetite
Numbness and tingling in your hands and feet (peripheral neuropathy)
Cough
Shortness of breath
Hair loss
Skin rash

The most common side effects of carboplatin include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
A drop in levels of minerals in your blood such as sodium, potassium, calcium and magnesium
Feeling or being sick
Hair loss
Fatigue and weakness

The most common side effects of gemcitabine include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Change to the way your liver works
Blood and protein in your urine
Feeling or being sick
Diarrhoea
Constipation
Sore mouth and sore eyes
Swelling in your hands, feet or face due to a build up of fluid
High temperature (fever)
Skin rash
Breathing problems
Flu like symptoms
Hair loss
Tingling or prickling of your skin
Itching