A trial looking at zoledronate or ibandronate for breast cancer that has spread to the bones (ZICE trial)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared zoledronate through a drip with ibandronate tablets. The treatment was for bone weakness and bone pain caused by breast cancer that has spread. This trial was supported by Cancer Research UK.

When cancer spreads to the bone, it can make the bone weaker and more prone to damage and fractures. It can also be painful. Drugs called bisphosphonates can help to slow down damage to the bones and reduce pain. Zoledronate (Zometa) and ibandronate (Bondronat) are both bisphosphonates.

When this trial was done, doctors often used zoledronate to treat breast cancer that had spread to the bone. You have this through a drip into a vein (an infusion). But they wanted to see if ibandronate, which you take as a tablet, was as good. The research team looked at what doctors call skeletal related events to see how well the treatments worked. This means things such as fractures, or needing radiotherapy for pain relief.

The aim of this trial was to see if ibandronate tablets are as good as zoledronate for breast cancer that has spread to the bone.

Summary of results

The research team found that zoledronate was better than ibandronate at preventing fractures, and other bone problems, in people with breast cancer that had spread to their bones.

This trial recruited over 1,400 people with breast cancer that had spread to at least 1 area of bone. The people taking part were put into 1 of 2 groups at random.

  • 697 people had zoledronate through a drip into a vein every 3 to 4 weeks
  • 704 people had ibandronate tablets every day

The research team looked at how many people had bone problems, and found that

  • 284 out of 697 people (41%) who had zoledronate had a total of 647 problems
  • 293 out of 704 people (42%) who had ibandronate had a total of 787 problems

When they looked at how many people were living 2 years after starting treatment, they found it was nearly the same in both groups. A few more people who had zoledronate had side effects, but both treatments were safe to use.

A study called the QUALZICE study has also been done. This looked at the quality of life of both groups of patients in this trial.  The research team doing the QUALZICE study concluded that patients preferred taking ibandronate tablets to having zoledronate through a drip.

The ZICE trial team concluded that zoledronate was a bit better than ibandronate at preventing bone problems such as fractures. But as they were both safe, they suggest that ibandronate could be used if it is better for the patient to take tablets rather than have regular infusions.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof P Barrett-Lee
Dr N Murray

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Roche Products Limited
Velindre NHS Trust
Wales Cancer Trials Unit

Other information

This is Cancer Research UK trial number CRUKE/04/022.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 790

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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