A study looking at what happens to breast cancer cells in women taking an aromatase inhibitor (VERB)

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:

Other

This study is looking at proteins called oestrogen receptors in breast cancer, in women taking aromatase inhibitors. This study is supported by Cancer Research UK.

More about this trial

Hormones are chemical messengers that control the growth and activity of normal cells. The female sex hormone oestrogen can stimulate some breast cancers to grow. It does this by joining (binding) to oestrogen receptors Open a glossary item . These oestrogen receptors then bind to the DNA of the cell.

Doctors treat breast cancers that have these receptors (ER positive breast cancers) with hormone therapy (also called endocrine therapy). This stops oestrogen stimulating the breast cancer cells to divide and grow. But sadly it does not help everyone.

In this study, researchers want to find out why. They will look at samples from women who are having a type of hormone therapy called an aromatase inhibitor before and after they have started treatment. They hope to better understand how these drugs work, and why they work better for some women than others. They also hope their work will lead to new drugs being developed for breast cancer.

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help women with breast cancer in the future.

Who can enter

This study is recruiting women who are being cared for by doctors at Imperial College NHS Healthcare Trust. If you are suitable for this study, one of the study team will ask if you would like to take part. Women taking part in this study will

Have breast cancer that is newly diagnosed, or has just come back after treatment
Have breast cancer containing oestrogen receptors (ER positive breast cancer)
Have reached the menopause (you have not had a period for at least a year or blood tests confirm you have reached the menopause or you have had both ovaries removed or had radiotherapy at least 3 months ago to stop your ovaries working)
Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have cancer that can be easily measured by a physical examination or scan
Have satisfactory blood test results
Be willing to allow doctors to remove an extra sample of breast cancer tissue (biopsy) for the study

You cannot enter this study if you

Have any condition that would make it unsuitable or unsafe for you to have an extra biopsy for the study
Are having treatment as part of another clinical trial

Trial design

This study will recruit 84 women. Everyone taking part will have a course of aromatase inhibitor Open a glossary item tablets. The type of aromatase inhibitor you take will depend on what your cancer specialist recommends.

12 weeks after starting hormone therapy, you have a series of tests, which include

Having your tumour measured by the study doctor – this should not cause you any discomfort
Taking a sample of cancer tissue from your breast using an ultrasound scan to guide the procedure (biopsy)
A blood test (about 3 teaspoons of blood)

If you did not have a biopsy taken for research when you had your original biopsy, the team will ask if you would be willing to have another one taken for the study. The team will also measure your cancer and take blood samples when you come to the hospital for routine check ups during and after your treatment.

If you have surgery, or need to have any fluid removed from your tummy area (abdomen) or lungs, the team will ask if they can also study samples from these procedures.