CompletedPhase IIInterventional

Safety of AZD4547 in breast cancer patients

Hormone therapy is a common and effective treatment for breast cancer that is fuelled by oestrogen. However, over time, the cancer can become resistant and start growing again despite medicines like anastrozole or letrozole. This phase II clinical trial is looking at whether adding an experimental drug called AZD4547 can help overcome this resistance. AZD4547 works by blocking specific growth signals in cancer cells. Researchers are comparing two main approaches: continuing anastrozole or letrozole alongside AZD4547, versus switching to a different standard hormone medicine called exemestane on its own. The study aims to find out if the new combination is safe, manageable, and better at slowing down or shrinking the cancer. It is open to post-menopausal women whose breast cancer has returned or progressed while taking anastrozole or letrozole.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Imperial College London (UK)

Enrolment target

Start

23 Jul 2012

Estimated completion

31 Dec 2015

Breast cancer

What is this study about?

Many breast cancers rely on the hormone oestrogen to grow. These are called oestrogen receptor-positive (or ER-positive) breast cancers. Common treatments known as aromatase inhibitors—such as anastrozole and letrozole—work by lowering oestrogen levels in the body to starve the cancer cells. While these medicines often work well for a long time, the cancer can eventually find new ways to grow and spread.

When standard hormone therapy stops working, doctors typically switch patients to another type of hormone tablet, such as exemestane. However, researchers are searching for better ways to keep the cancer under control. In some tumours, a cell-signalling pathway called FGFR becomes overactive, helping cancer cells survive even when oestrogen is blocked. AZD4547 is a new targeted drug designed specifically to turn off this growth signal.

This trial investigates whether combining AZD4547 with your existing hormone therapy (anastrozole or letrozole) can stop the cancer from growing better than switching to exemestane alone. By taking part, patients help doctors understand whether targeting both oestrogen and the FGFR pathway at the same time is safe and offers a more effective treatment option for the future.

Key takeaways

Tests whether adding AZD4547 to existing hormone therapy works better than standard exemestane.
Aimed at post-menopausal women with ER-positive breast cancer that has progressed on anastrozole or letrozole.
Requires a tumour biopsy to check for specific tumour markers.
Participation includes regular scans, hospital visits, and blood tests to monitor your safety.
Taking part is entirely voluntary, and you can stop at any time.

Who may be eligible?

This trial is for women aged 25 and over who have gone through the menopause and have ER-positive breast cancer. It is designed specifically for people whose cancer has returned or continued to grow while they were taking either anastrozole or letrozole.

To join, you must be generally well enough to carry out daily activities and look after yourself (an ECOG performance status of 0 or 1). You will also need to have at least one area of cancer that can be measured on a scan such as a CT or MRI scan so the doctors can track your response to treatment.

Because the study investigates a targeted pathway, participants in the main part of the trial will need to provide a small sample of tumour tissue (a biopsy) so the laboratory can check for specific cell markers. Your trial doctor will review your medical history, previous treatments, and scan results to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman aged 25 or over.
I have gone through the menopause.
I have oestrogen receptor-positive (ER+) breast cancer.
My cancer has grown or returned while taking anastrozole or letrozole.
I am generally active and able to look after myself day-to-day.
I am willing to have a tumour biopsy and regular hospital check-ups.

Answer every question to see your result.

What does participation involve?

If you take part, you will be allocated to a treatment group. Depending on the part of the trial you join, you may receive the new drug AZD4547 as tablets along with your current hormone therapy (anastrozole or letrozole), or you may receive standard exemestane tablets. You will be told exactly how and when to take your medicines at home.

You will need to visit the hospital regularly, especially during the first few months. Visits will involve routine health checks, blood tests, physical examinations, and regular scans (such as CT or MRI scans) to check how your cancer is responding. A small tumour biopsy is also required at the start. You will continue the trial treatment for as long as it helps keep your cancer stable and any side effects remain manageable, followed by routine follow-up visits to check on your health.

Potential risks and benefits

Taking part may help slow down or shrink your cancer, and the results will help improve future care for women in a similar situation. However, there is no guarantee that the treatment will work for you personally. Like all cancer medicines, AZD4547 and hormone tablets can cause side effects, which the medical team will monitor closely and help manage. Taking part is completely voluntary. You have the right to leave the trial at any time without giving a reason, and your standard NHS medical care will not be affected.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Charing Cross Hospital
Unverified
London, England
Freeman Road Hospital
Unverified
Newcastle upon Tyne, England
Addenbrookes
Unverified
Cambridge, England
Beatson West of Scotland Cancer Centre
Unverified
Glasgow, Scotland
The Christie
Unverified
Manchester, England
Russells Hall Hospital
Unverified
Dudley, England

Common questions

What is the purpose of this clinical trial?

The trial aims to find out if adding a new drug, AZD4547, to standard hormone treatment is safe and more effective than switching to exemestane for breast cancer that has started growing again.

Do I have to pay to take part?

No. In the UK, clinical trial medications, extra tests, and hospital appointments are provided free of charge through the trial and the NHS. Some travel expenses may also be refunded.

What is a biopsy and why is it needed?

A biopsy is a small sample of tissue taken from the tumour using a needle under local anaesthetic. It is needed so the laboratory can test whether your cancer has the specific protein targets that AZD4547 aims to block.

Can I leave the study if I change my mind?

Yes. You are completely free to leave the trial at any point. Your decision will not change your relationship with your healthcare team or affect the quality of your regular NHS care.

How often will I need to visit the hospital?

You will need to visit more often during the first few weeks for monitoring and blood tests. Once your treatment is settled, visits usually coincide with your regular monthly treatment cycles and scheduled scans.

How to find out more

Philip Badman

radical@imperial.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.