I want to take part, what do I
do next?
With your help we can
If you are interested in this trial, please
contact your research team (named
below). They will confirm if you are
suitable for the trial and give you full
information on how to participate.
make the Persephone trial a
success and help to shape
the future of breast cancer
treatment
You may be eligible to participate
in the Persephone clinical trial
[Label or stamp with site’s contact information]
This trial is run by Cambridge University Hospitals
NHS Foundation Trust and the University of
Cambridge in collaboration with Warwick Clinical
Trials Unit.
This trial is funded by the Department of Health.
The clinical and scientific rationale has been
reviewed by national and international experts.
For more information:
http://www.warwick.ac.uk/go/persephone
Version 2, 2nd August 2010
Are you receiving
Herceptin®?
This trial has been reviewed and approved by the
North Manchester Ethics Committee.
Breast cancer treatment
Why consider Persephone ?
What happens during the
Persephone trial?
Herceptin® is a drug that is currently given
to HER2+ breast cancer patients for 12
months. It has proved to be a major advance
in breast cancer and has demonstrated the
value of targeted therapy.
To help us to discover if 6 months of
Herceptin® is as clinically effective as 12
months
If eligible you will be allocated to receive
either 6 or 12 months of Herceptin®. You will
receive Herceptin® and continue to visit the
hospital for regular checks.
There is now growing evidence to suggest
that a shorter duration of Herceptin® will
have the same clinical effect.
To assess the Quality of Life of patients
receiving 6 and 12 months of
Herceptin®
To reduce the risk of cardiac toxicity.
Herceptin® is a powerful treatment which
can damage the heart
All patients will receive 6 months of Herceptin®.
Patients in the 12 months group will continue to
receive Herceptin® for a further 6 months. You
will be told how long your Herceptin® treatment
will last for as soon as you consent to be in the
trial. Occasionally you will be asked to complete
a Quality of Life questionnaire.
What is Persephone ?
Persephone is a clinical trial comparing 6
months and 12 months of Herceptin®.
12 months treatment is an arbitrary figure as
the initial studies compared patients who
weren't given Herceptin® to those given the
drug for 12 or 24 months.
For more information:
http://www.warwick.ac.uk/go/persephone
To be involved in research and to help
define treatment for future patients
Reduce the amount of time you
experience the side-effects of Herceptin®
Reduce the inconvenience and costs of
hospital visits
To be one of the 13,000 patients being
recruited worldwide into Herceptin®
duration trials.
Am I eligible to participate?
To participate in this study you must meet
certain conditions including:
- recent diagnosis of breast cancer showing
high levels of the HER2 molecule
- due to receive chemotherapy and
Herceptin® (you may have received less than 6
months of Herceptin® so far)