A trial looking at a blood thinning drug for women with breast cancer (TIP)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2

This trial is looking at a blood thinning drug called rivaroxaban to see if it can help women with early breast cancer.

It is for women with oestrogen receptor negative Open a glossary item (ER negative) breast cancer who are going to have surgery or chemotherapy.

More about this trial

People with cancer have a high risk of having blood clots (thrombosis). This is because cancer cells make chemicals that stimulate the blood to form blood clots.

Researchers think that having a large amount of these chemicals can also help the cancer to grow and spread.

Rivaroxaban is a blood thinning drug (anticoagulant). It blocks the clotting chemicals and prevents blood clots from forming. It is used in people who:

  • have had surgery to replace their hip (total hip replacement)
  • have a high risk of stroke Open a glossary item

Women with early breast cancer often have surgery or chemotherapy. Doctors want to see if having rivaroxaban before surgery or chemotherapy has any anti cancer effect on the breast cancer. They also want to see if rivaroxaban can help to stop the cancer from spreading.

To check for this they will look at substances called biomarkers Open a glossary item in blood and tissue samples taken before and after surgery or chemotherapy.

In this trial, women have 1 of the following:

  • rivaroxaban (20 mg) and surgery or chemotherapy
  • rivaroxaban (10 mg) and surgery - this group is now closed
  • surgery or chemotherapy

The main aim of this trial if to find out if having rivaroxaban before surgery or chemotherapy has an anti cancer effect.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if you are a woman and all of the following apply:

  • You have early breast cancer (stage 1 to 3)   
  • Your breast cancer is oestrogen receptor negative (ER negative)
  • Your breast cancer measures at least 10 mm and the trial doctors are able to take some tissue from it (biopsy) Open a glossary item 
  • You are going to have surgery or chemotherapy as a treatment for breast cancer
  • You have satisfactory blood tests results
  • Your kidneys work well
  • You can swallow tablets and are able to absorb them
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) and this has not changed in the last 2 weeks  
  • You are aged 18 years or over
  • You are willing to use reliable contraception during treatment and for 2 weeks after the end of treatment if there is any possibility you could become pregnant

You cannot join this trial if any of these apply:

  • You have had treatment for breast cancer or any other cancer (apart from non melanoma skin cancer)
  • You take blood thinning drugs (apart from drugs like aspirin or clopidogrel to prevent a blood clot or for a condition called atrial fibrillation)
  • You take drugs to treat fungal infections from a group called azole-antimycotics
  • You take drugs that affect some enzymes called CYP
  • You take an antibiotic called clarithromycin
  • You take drugs to treat HIV
  • You take a drug called dronedarone to help your heart beat regularly
  • You have taken a drug to dissolve blood clots (a fibrinolytic) in the last 48 hours
  • You have had major surgery or trauma in the past 4 weeks
  • Your blood doesn’t clot very well (haemorrhagic disorder) or you have a condition that makes you bleed very easily called active bleeding diathesis
  • You have had bleeding in the inside of your brain, eyes, spine, tummy (retroperitoneal) or in the inside of your joints that wasn’t caused by trauma
  • You have had a bleed inside your digestive system Open a glossary item in the past year or an open sore (ulcer) in the lining of your stomach or the part of the intestine just beyond it (duodenum Open a glossary item) in the last 30 days    
  • You have problems in your brain such as a brain tumour Open a glossary item, poorly formed vessels (arteriovenous malformation) or an aneurysm
  • You have high blood pressure (higher than 180 over 100 mmHg) that is not controlled by medication
  • You have an active infection Open a glossary item
  • You have HIV
  • You have hepatitis B or hepatitis C
  • You are allergic to rivaroxaban
  • You are taking part in another clinical trial 
  • You have any other serious medical condition that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need about 81 women across the UK to take part.

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • rivaroxaban (20 mg) and surgery or chemotherapy
  • rivaroxaban (10 mg) and surgery - this group is now closed
  • surgery or chemotherapy

Neither you nor your doctor are able to decide which group you are in. 

TIP trial diagram

If you have rivaroxaban, you have tablets once every day for about 2 weeks before surgery or chemotherapy. You stop taking rivaroxaban around 24 hours before your surgery or chemotherapy.

Everyone taking part has their surgery or chemotherapy about 2 weeks after starting in the trial.

Blood tests
You have some extra blood tests as part of this trial. The researchers want to:

  • see how the clotting chemicals in the blood are affected by cancer and by the drug
  • find cancer cells in the bloodstream (called circulating tumour cells or CTCs) 
  • understand who benefits most from blood thinning drugs

You have blood tests on your first visit (before you start rivaroxaban if you have it) and at the end of treatment. 

Tissue samples
The trial team will ask to use a sample of your cancer taken when you were diagnosed. They also ask for samples of your cancer taken during surgery, if you have this. 

If you have chemotherapy, the team will ask to take a tissue sample (a biopsy) before you start treatment. 

They want to look at both samples to see if rivaroxaban changes cancer cells.

Once the researchers have looked at the samples, they store them in a laboratory for up to 15 years and use them in future studies.

Hospital visits

You see a doctor and have some tests before taking part. These tests include:

  • a physical examination
  • blood tests

You may have to go to hospital to collect the study drug.

After about 2 weeks of your surgery, or biopsy, you see the trial doctor to check:

  • how you are 
  • if you have had side effects from rivaroxaban

Side effects

The trial team monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

Less than 1 in 10 people (10%) have the following side effects:

  • tiredness (fatigue)
  • feeling or being sick
  • diarrhoea or constipation
  • a drop in red blood cells Open a glossary item (anaemia) 
  • a high temperature (fever)
  • stomach pain and headaches
  • low blood pressure
  • bleeding of the nose, gums or the inside of your body
  • dizziness
  • itching
  • problems with your kidneys
  • fluid retention 

We have information about side effects of breast cancer surgery.

Location

Bolton
Leeds
Liverpool
Macclesfield
Manchester
Wirral

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

Dr. Cliona Kirwan

Supported by

Liverpool Cancer Trials Unit
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester (UHSM)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13457

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

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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