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TRANSBIG<br />
Translating molecular knowledge<br />
into early breast cancer management:<br />
building on the Breast International<br />
Group (BIG) network for improved<br />
treatment tailoring<br />
Summary<br />
Keywords | Breast cancer | clinical trials | molecular signature |<br />
The key to individualising treatment for cancer lies in fi nding<br />
a way to quickly ‘translate’ the discoveries about human<br />
genetics made by laboratory scientists in recent years into<br />
tools that physicians can use to help make decisions about<br />
the way they treat patients. This area of medicine that links<br />
basic laboratory studies to the treatment of patients is<br />
called translational research. TRANSBIG has been created<br />
as a multidisciplinary network of excellence, devoted specifi<br />
cally to this type of research in breast cancer.<br />
TRANSBIG is a research network of 40 world-class institutions<br />
in 21 countries. Each participating organisation brings<br />
with it expertise that ranges from being specialised in cutting-edge<br />
biomedical technologies and cancer treatment<br />
programmes to lobbying governments on behalf of patient<br />
groups and supporting cancer societies. As a network,<br />
TRANSBIG will be dedicated to high-level collaboration<br />
that will contribute dramatically to advancing individualised<br />
treatment for breast cancer patients. Among its many<br />
strengths is the fact that it is linked to an already existing<br />
network of groups around the world that conduct clinical<br />
breast cancer research together – the Breast International<br />
Group (BIG). BIG’s 44 member organisations are active in<br />
40 countries.<br />
The headquarters is located in Brussels, and it coordinates<br />
the activities of both TRANSBIG and BIG. By linking the two<br />
networks and by benefi ting from a central coordinating<br />
body, the fragmentation currently existing in the fi eld will<br />
be reduced, and translational research in Europe will be<br />
strengthened and accelerated. New technologies will only<br />
gain acceptance by physicians and patients after fi rst being<br />
validated in large, independent clinical trials. Microarray<br />
technology has enabled scientists to determine the signature<br />
of individual tumours, but it must be proven that this<br />
information is more reliable than existing methods for<br />
determining how best to treat individual patients.<br />
Problem<br />
Breast cancer is the most common cancer among women in<br />
developed countries, with one out of eight to ten women<br />
developing the disease in her lifetime. While incidence has<br />
steadily increased over the past decades, a slight decrease in<br />
deaths from breast cancer has only recently been noted, and<br />
that only in a few countries. Breast cancer is curable in about<br />
70 % of cases if diagnosed and treated early enough. But<br />
because of uncertainty over the best treatment in individual<br />
cases, many women receive chemotherapy or hormonal treatment<br />
after surgery, based on the assumption that there is<br />
a high risk of their breast cancer recurring. Some women benefi<br />
t signifi cantly from such treatment, others only very little or<br />
not at all. The reason for this is because breast cancer is a disease<br />
that develops very diff erently in each woman. If individual<br />
tumours were better understood, physicians would be able to<br />
make more enhanced decisions about which treatments are<br />
best for individual patients and which patients need no further<br />
treatment after surgery. Presently it is estimated that about 12<br />
to 20 % of patients are over-treated, resulting in avoidable costs<br />
to both health services (fi nancial) and patients (side-eff ects).<br />
Aim<br />
The aims of this network are:<br />
• to develop ways of individualising breast cancer treatment,<br />
so that treatment is tailored to the person receiving it;<br />
• to integrate, strengthen and facilitate translational clinical<br />
breast cancer research in Europe and internationally by<br />
linking it to an existing network for clinical breast cancer<br />
trials (BIG);<br />
• to develop and run a major clinical trial aimed at validating<br />
the hypothesis that understanding the genetic makeup<br />
(signature) of a tumour can lead to better targeted<br />
treatment.<br />
Although TRANSBIG will ultimately develop many projects,<br />
it will start with a clinical trial called MINDACT (Microarray<br />
for Node Negative Disease may Avoid Chemotherapy). This<br />
trial will compare two diff erent ways of assessing the probability<br />
or risk that a woman’s breast cancer will come back.<br />
The traditional method is based on international guidelines<br />
and looks at specifi c characteristics such as the size of a patient’s<br />
tumour and whether the disease has spread to the<br />
lymph glands (nodes).The new method uses microarrays as<br />
a way of analysing the genetic components of a tumour.<br />
Specifi cally, traditional methods of assessing risk will be<br />
compared to a 70-gene tumour ‘signature’ identifi ed by<br />
a group of scientists at the Netherlands <strong>Cancer</strong> Institute<br />
that appears to predict very accurately whether a particular<br />
woman’s breast cancer will come back. MINDACT will involve<br />
222 CANCER RESEARCH PROJECTS FUNDED UNDER THE SIXTH FRAMEWORK PROGRAMME
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