LOTUS: LOng-Term follow-Up Study of triple-negative breast cancer
The LOTUS study is an international research project following people who were treated for triple-negative breast cancer. It is specifically designed for people who previously took part in an earlier clinical trial known as the BEATRICE study. Triple-negative breast cancer can be harder to treat because standard hormone therapies do not work on it. The original BEATRICE trial tested whether adding a drug called Avastin to standard chemotherapy helped prevent cancer from returning. LOTUS does not test any new medicines. Instead, it tracks your health over time by gathering information from routine check-ups and medical records. By learning how people are doing many years after treatment, researchers hope to understand the long-term benefits and lasting effects of cancer therapies. This knowledge will help doctors make better treatment decisions for people diagnosed with triple-negative breast cancer in the future.
At a glance
What is this study about?
Triple-negative breast cancer is a type of breast cancer where the cells do not have receptors for the hormones oestrogen or progesterone, or for a protein called HER2. Because of this, common hormone treatments are not effective, making chemotherapy the main medical option. Years ago, an international clinical trial called BEATRICE was launched to see if adding a targeted drug named Avastin (bevacizumab) to chemotherapy could help lower the chance of cancer returning.
The LOTUS study is a long-term follow-up of that original research. Rather than testing a new medicine, LOTUS checks in on people who were part of the BEATRICE trial to see how they are doing years after completing their treatment.
Tracking health over many years is an essential part of cancer research. Some benefits or side effects of treatments may only become clear a long time after therapy has finished. By looking at long-term survival and overall wellbeing, researchers can build a complete and honest picture of how these treatments perform throughout a person's life.
The information collected through LOTUS will help doctors understand what to expect in the years following treatment. Ultimately, this valuable insight will guide better care and support for people diagnosed with triple-negative breast cancer in the years to come.
Key takeaways
- LOTUS is a long-term follow-up study for people who previously took part in the BEATRICE trial.
- The study monitors your health and wellbeing years after your initial breast cancer treatment.
- There are no new medicines, experimental therapies, or extra invasive procedures involved.
- Health information is gathered mainly through routine check-ups and medical records.
- Taking part helps doctors improve future treatments and care for triple-negative breast cancer.
Who may be eligible?
To take part in the LOTUS study, you must have been a participant in the earlier BEATRICE breast cancer trial. You also need to be aged 18 or older, able to give your consent, and currently receiving follow-up care at a hospital or clinic that is taking part in the LOTUS study. Both men and women can join.
You cannot join LOTUS if you stopped taking part in the follow-up checks during the original BEATRICE study. You will also not be eligible if you were given hormone therapy (such as tamoxifen or letrozole) after finishing your chemotherapy, as triple-negative breast cancer is not treated with these medicines.
Your cancer doctor or clinical research nurse can check your past hospital notes to see if you were enrolled in the BEATRICE trial and confirm whether you meet the criteria for LOTUS.
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 aged 18 or older.
- I took part in the BEATRICE clinical trial for breast cancer.
- I still attend follow-up care at a hospital participating in the LOTUS study.
- I did not take hormone therapy tablets after finishing my chemotherapy.
- I am happy to let researchers follow my health progress over time.
What does participation involve?
Because LOTUS is an observational follow-up study, you will not receive any new medicines, injections, or experimental treatments. Taking part simply means allowing doctors to keep track of your health over time. In most cases, information is gathered during your regular NHS check-up appointments or taken directly from your medical records. You may occasionally be asked to complete a short questionnaire about your health and wellbeing. There are no extra invasive tests or scans required specifically for this study. The team will continue to follow your health progress for several years as part of your ongoing care.
Potential risks and benefits
Locations (1)
- Leeds Institute of Clinical ResearchCity onlyLeeds, England
Common questions
Will I have to take any new medicines in this study?
No. LOTUS is purely a follow-up study. You will not be given any new trial drugs or treatments.
Do I have to travel to extra hospital appointments?
Usually, no. Study reviews are generally planned to match your normal clinic visits, or researchers simply review your medical notes.
Why do researchers want to follow me up years later?
Long-term studies help doctors learn about any late side effects and understand how treatments protect health many years down the line.
Can I leave the study if I change my mind?
Yes. You can withdraw from the study at any time without giving a reason, and your regular medical care will stay exactly the same.
How do I find out if I was in the BEATRICE trial?
Your hospital cancer team or oncologist can easily check your medical records to see if you took part in the BEATRICE study.
How to find out more
David Cameron
Always speak to your GP or specialist before deciding to take part in a study.
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