A study of the long term outcomes and impact of treatment for triple negative breast cancer (LOTUS)

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 the long term outcomes and impact of treatment for triple negative breast cancer. The study is only open to those people with triple negative breast cancer who took part in the BEATRICE trial.

The BEATRICE trial looked at bevacizumab (Avastin) alongside standard chemotherapy as treatment for people with triple negative breast cancer.

More about this trial

The LOTUS study is a follow on study of the BEATRICE trial. The researchers want to contact people who took part in the BEATRICE trial to find out how they are. They will also look at their medical records to find out the information.

The aims of the LOTUS study are to find out

  • How many people are alive and cancer free 10 years and 15 years after taking part in the BEATRICE trial
  • How many people who have triple negative breast cancer develop heart problems

Please note there will be no benefit if you agree to join this study. But the information the researchers gain may benefit people in the future who have triple negative breast cancer.

Who can enter

You can join the LOTUS study only if you took part in the BEATRICE trial.

You cannot join this study if any of these apply. You

  • Have stopped being followed up as part of the BEATRICE trial
  • Have had hormone therapy after the chemotherapy following your surgery

Trial design

The researchers need 250 to 500 people to join.

The study team will invite people to join at one of their routine cancer clinic appointments. Or a member of the team may call you to introduce the study. If you are interested they will post you a patient information sheet and consent form.

Once a year the researchers will collect information about your general health, if your cancer has come back and any other treatment or medication you have had. They will collect the information until 10 years after you first agreed to take part in the BEATRICE trial.

Hospital visits

As far as possible the information will collected at your routine clinic appointments. Or a member of the study team may phone you.

This will be for a maximum of 5 times, depending on when you agreed to take part in the LOTUS study.

10 years after you joined the BEATRICE trial, you will have a heart scan (ECHO Open a glossary item).

Side effects

There are no side effects if you agree to take part in the LOTUS study.

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

Professor David Cameron

Supported by

Experimental Cancer Medicine Centre (ECMC)
Leeds Institute of Clinical Trials Research (University of Leeds)
NIHR Clinical Research Network: Cancer
Roche
University of Leeds

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12744

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

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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