A study of why an uncommon type of lymphoma happens after having breast implants (BASILICA)

Cancer type:

Blood cancers

Breast cancer

Lymphoma

Status:

Open

Phase:

Other

This study is looking at why anaplastic large cell lymphoma occurs in a small number of women after having a breast implant put in.

More about this trial

A couple of possible long term problems after having reconstruction using a breast implant are developing:

a rare type of breast lymphoma called anaplastic large cell lymphoma
scarring tissue around the implant causing pain and distortion of the implant and breast (capsular contracture)

In this study researchers want to learn more about why these problems develop. To do this they will look at tissue samples and blood samples from women who develop these problems as well as patients who are having breast implants for the first time.

The aim of the study is to find out more about anaplastic large cell lymphoma and why it develops after a having a breast implant.

Who can enter

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

There 3 groups in this study:

group A
group C
group N

Who can take part

You may be able to join this study if you are:

going to the Royal Marsden Hospital
are at least 17 years old

And one of the following apply. You:

have anaplastic large cell lymphoma related to a breast implant (group A)
have a capsule around your implant or you have a diagnosis of capsular contraction (group C)
are having surgery to put in an implant (group N)

Who cannot take part

Everyone

You cannot take part if the multidisciplinary team Open a glossary item (MDT) are unable to recommend you for surgery.

Group C

You cannot join group C if either of the following apply. You have had:

surgery to replace more than one implant exchange previously
a lot of surgery to the tissue surrounding the implant (the capsule)

Group N

You cannot join group N if you have had previous surgery to put in an implant.

Trial design

There are 3 groups in this study.

Group A - women who have anaplastic large cell lymphoma

In group A the team need:

10 women who are to have surgery to remove their implant
10 women who have already had surgery to remove their implant

Women who are to have surgery

You have surgery to remove the lymphoma and the implant.

The team take blood samples:

before starting and after finishing chemotherapy (if you are having chemotherapy)
before surgery
about 3 months and 1 year after surgery

After surgery a cell specialist (pathologist Open a glossary item ) examines the removed tissue in the lab. When they have completed their examination the study team ask for a piece of the tissue sample.

The team use these samples to learn more about anaplastic large cell lymphoma and find:

whether there are changes in the number of white blood cells
small pieces of circulating gene information (ctDNA )
the level of antibodies
changes to proteins, cells and DNA

Women who have had surgery

The team ask for a piece of the tissue sample (biopsy):

that your doctor took to diagnose anaplastic large cell lymphoma
from the tissue removed by surgery

Group C - women who have a capsule around the implant or have capsular contraction

The team need 50 women to join this group.

You give a blood sample before surgery and 3 months later.

They ask for a sample of tissue that is removed when you have surgery.

Group N - women who are having surgery to put in an implant

The team need 30 women to join this group.

You give a blood sample:

before surgery to have your implant put in
3 months after surgery
1 year after surgery

For future research

The team ask your permission to store any leftover tissue from the routine samples. Researchers will use these stored samples to find out more about anaplastic large cell lymphoma.

Hospital visits

The team will where possible take the blood samples when you go into hospital for your routine samples. On these occasions your visit into the hospital might be longer than usual.

Side effects

The team don’t expect any side effects if you agree to take part in the study.

There is a very small risk that researchers might find new genes that might affect you or your family. In this case the team will refer you to a genetic counsellor. Your team will talk to you about this and explain more before you agree to take part.