“I had treatment last year and I want to give something back.”
A study of zoledronic acid for early breast cancer (ZOLMENO study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at how zoledronic acid works in women with early breast cancer. And why it seems to only help women who have been through the menopause.
More about this trial
Bisphosphonates are drugs that make bones stronger. Some women have them as part of their breast cancer treatment to prevent bone damage. You might have a type of bisphosphonate drug called zoledronic acid.
Early research shows that if a woman has zoledronic acid then her cancer is less likely to come back or spread to the bones. But this benefit is only seen in women who have been through the menopause. And not in women who haven’t.
Researchers don’t know exactly why this is. They think it has something to do with changing hormone levels that happen after the menopause. But they don’t know for sure. So, they want to find out more.
In this study, they are looking at the changes that zoledronic acid causes in blood and cancer cells. They hope this information will help to predict who will benefit most from zoledronic acid.
The aim of this study is to find out how and why zoledronic acid works in women with breast cancer.
Please note, taking part in this study might not benefit you directly. But it might help people with early breast cancer in the future.
Who can enter
- have breast cancer that hasn’t spread further than lymph nodes under the arm (early breast cancer)
- have cancer that measures more than 1 cm across
- have surgery planned as the first treatment for breast cancer
- are well enough to be up and about for at least half the day (performance status 0,1 or 2)
- have satisfactory blood test results
- have had any other cancer in the past apart from non melanoma skin cancer or very early bladder cancer
- have a problem with your bone marrow
- have had zoledronic acid or any other bisphosphonate drug in the past
- are using hormone replacement therapy (HRT), you use contraceptives including the pill or implants or you have had depo injections in the last 30 days
- have or have had jaw damage called osteonecrosis
- have or have had recent dental or jaw surgery or have this planned
- are pregnant or breastfeeding
- have any other medical condition or mental health problem that the study team think would affect you taking part
- 40 women who have been through the menopause
- 40 women who haven’t
- a dose of zoledronic acid 1 week before surgery (Group A)
- a dose of zoledronic acid 3 weeks after surgery (Group B)
- using a syringe to remove some cells from your bone marrow
- removing a small piece of the marrow
You’ll see a doctor and have some blood tests before you join the study.
You have 3 to 4 extra visits if you join this study. Where possible you have them on the day of your routine visits.
At each visit, you’ll have a check up and blood tests.
- raised temperature
- bone, joint or muscle aches
- sore or itchy eyes
- stomach upset such as feeling or being sick, or diarrhoea
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.
Professor Janet Brown
Yorkshire Cancer Research
Weston Park Cancer Charity
University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust