A trial of ganetespib for advanced 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 2

This trial is looking at a new drug called ganetespib for breast cancer that has spread to another part of the body (advanced or metastatic breast cancer).

Researchers are looking for new ways to treat secondary breast cancer. In this trial, they are looking at a drug called ganetespib.

Ganetespib (also known as STA-9090) is a type of targeted therapy drug called a heat shock protein 90 inhibitor. It stops signals that cancer cells use to divide and grow.

The trial is for women who have not had any other treatment for advanced breast cancer. There are 2 groups of women taking part

Women whose cancer cells have a large amount of receptors for a protein called HER2 (HER2 positive breast cancer)
Women whose cancer cells do not have large amounts HER2 receptors and are not sensitive to the female hormones oestrogen or progesterone (triple negative breast cancer)

The aim of the trial is to see if ganetespib is safe and if it helps women with advanced breast cancer.

Who can enter

You may be able to enter this trial if

You are a woman and at least 18 years old
You have breast cancer that has spread to another part of your body (stage 4) – if you have inflammatory breast cancer, you may be able to take part if your cancer has spread to the skin over your breast (stage 3B)
Tests show that your cancer either has receptors for HER2 (it is HER2 positive) or it doesn’t have receptors for oestrogen, progesterone or HER2 (it is triple negative breast cancer)
Your cancer can be seen and measured on a scan
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood test results
You are willing to use reliable contraception during the trial and for a month afterwards if there is any chance you could become pregnant

If you have HER2 positive breast cancer, you must have had trastuzumab (Herceptin) or another drug that targets HER2 after you had surgery to remove your breast cancer, and you must have finished this treatment at least 6 months ago.

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord (central nervous system), unless this has been successfully treated and is not getting any worse
Have cancer that has spread to your bones, but nowhere else in your body
Have already had treatment for secondary breast cancer (there may be exceptions if you have inflammatory breast cancer or you've only had one type of hormone therapy – the trial team can explain this)
Have only just been diagnosed with HER2 positive breast cancer and have not had any treatment yet
Have had radiotherapy to your cancer and this is the only area of cancer that can be measured (you may have had radiotherapy to another part of your body, as long as the treatment has finished and you have recovered from any side effects)
Are taking drugs to prevent damage to your bones – you may be able to take part if you take drugs to treat problems caused by cancer that has spread to your bones
Have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
Have certain heart problems – the trial team can advise you about this
Have lost a lot of weight (more than 10% of your body weight) in the last 4 weeks
Have not recovered from side effects of earlier cancer treatment - unless they are mild
Have any other medical condition that the trial team think could affect you taking part in the trial
Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 70 women around the world.

You have ganetespib through a drip into a vein twice a week for 3 weeks, followed by a week without treatment. Each 4 week period is called a cycle of treatment.

As long as your cancer doesn’t get worse and you don’t have bad side effects, you have up to 3 cycles of treatment lasting 12 weeks. If your cancer stays the same size or gets smaller during treatment, the trial team may talk to you about continuing to take ganetespib for longer.

The researchers will use some of your blood and tissue samples to look at genes and proteins. They hope this will help them to understand more about breast cancer and how different people respond to treatment.

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 )
CT scan
MRI scan
PET scan

The trial doctor will also take a sample of your cancer (a biopsy Open a glossary item ) by putting a needle through your skin and into the cancer. The trial team must have a sample of your cancer, but if it is not possible to take a biopsy, your doctor may be able to get a sample of tissue that was removed in the past, for example when your cancer was first diagnosed.

You have ganetespib at the hospital. You have it twice a week, for 3 weeks out of 4. It takes about an hour each time. You have regular blood tests. You have a CT scan or PET scan after 3 weeks of treatment.

The trial team may ask you to have another biopsy after the first 3 weeks of treatment and again at the end of treatment. But you don’t have to have these biopsies if you don’t want to, you can still take part in the trial.

When you finish having treatment, you see the trial team again. You have a blood test and they may ask you to have another CT scan, MRI scan or bone scan.

Side effects

As ganetespib is a new drug, there may be side effects we don’t know about yet. The most common known side effects include

Diarrhoea
Sickness, tummy pain or an upset stomach
Feeling tired (fatigue)
Not wanting to eat
A drop in the number of red blood cells that can cause tiredness or shortness of breath
Headache
Problems sleeping
Changes to the way your liver works
Lack of fluid in your body (dehydration)
Feeling dizzy
Changes to the levels of sodium and potassium in your blood