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New study of
targeted therapies for breast cancer --
model for global clinical trials
Two targeted medications designed to treat an
aggressive form of breast cancer are being
tested in a new study involving 8,000
participants in 50 countries across six
continents -- a clinical trial that
investigators hope will provide a new model
for global cancer research.
This trial, dubbed ALTTO (Adjuvant Lapatinib
and/or Trastuzumab Treatment Optimization
study), will be one of the first global
initiatives in which two large, academic
breast cancer research networks covering
different parts of the world have jointly
developed a study in which all care and data
collection are standardized, regardless of
where patients are treated.
The networks are The Breast Cancer Intergroup of
North America (TBCI), based in the United
States, and the Breast International Group
(BIG) in Brussels, Belgium. TBCI consists of
six National Cancer Institute (NCI)-funded
clinical trials cooperative groups. NCI is
part of the National Institutes of Health.
ALTTO is designed to answer the most pressing
questions regarding use of two widely used
cancer agents: whether one agent is more
effective, which agent is safer for
patients, and what benefit will be derived
by taking the drugs separately, in tandem
order, or together."
The trial is a randomized, Phase III study, which
is considered a gold standard method for
proving drug effectiveness.
The two agents tested in ALTTO are drugs designed
to treat HER2-positive tumors, which is a
particularly aggressive form of cancer that
affects approximately 20 percent to 25
percent of breast cancer patients.
Both agents, trastuzumab (Herceptin) and
lapatinib (Tykerb), have already been
approved by the U.S. Food and Drug
Administration for use for treatment of
HER2-positive breast cancer.
ALTTO will provide the first head-to-head
comparison of trastuzumab and lapatinib in
the earliest, most treatable stages of
cancer. It will also be one of the first
large-scale studies to evaluate lapatinib’s
effectiveness in treating early breast
cancer.
HER2-positive breast cancer is caused by an
excess of HER2 genes or by over-production
of its protein, the HER2 cell surface
receptor.
Trastuzumab consists of large antibodies that
once injected into patients, latch on to the
portion of the HER2 protein that sits on the
outer surface of the cancer cell whereas
lapatinib acts by entering a cancer cell and
binding to the part of the HER2 protein that
lies beneath the surface of the cell.
The trial is unusual in that it has two different
designs depending on whether patients with
stage I or stage II breast cancer have
already been treated with chemotherapy.
The study thus will compare four different
regimens of targeted therapy administered
over a 52-week period. Patients will be
randomized to receive either trastuzumab or
lapatinib alone, or trastuzumab followed by
lapatinib, or the two treatments in
combination.
“There have been major improvements in the
management of patients with early breast
cancer in the last few years, so this new
study builds on this knowledge and sets an
example of the new era: good science, good
worldwide collaboration,” said Edith Perez,
M.D., an oncologist in the North Central
Cancer Treatment Group (NCCTG) at Mayo
Clinic in Jacksonville, Fla., who will lead
the study for TBCI.
“It may be that using two treatments that work in
different ways against HER2-positive breast
cancer offers a complementary strategy that
is more powerful than either drug alone.”
ALTTO will be one of the first trials of its
scope in which translational research --
taking science from bench to bedside --
plays a critical role, investigators say.
In ALTTO, biological material will be collected
from thousands of patients in order to
determine a tumor profile that responds best
to the drugs -- information that could lead
to individualized patient care and,
possibly, to development of next generation
agents.
“The difference between this study and many that
came before it is that the collection of
biological materials occurs as the trial is
being conducted, not as an afterthought.
While there are exceptions, not many companies or
organizations have been willing to invest in
that kind of research before,” said Martine
J. Piccart, M.D., Ph.D., professor of
oncology at the Université Libre de
Bruxelles, Belgium, and lead investigator
for BIG, which she founded in 1996.
“Now we have the chance to optimize therapy with
powerful drugs in order to provide the best
treatment possible for each of our
patients.”
Perez and Piccart led the development team of the
ALTTO trial and will act as the study’s
co-principal investigators.
On behalf of BIG and TBCI, these two lead
investigators have been working toward
collaborative clinical studies for a number
of years.
The ALTTO study, they say, represents a new
paradigm that blends the high standards of
both systems in order to test the latest
breast cancer treatments as efficiently as
possible in thousands of women worldwide.
"The NCI greatly appreciates the work that Mayo
Clinic, TBCI and BIG are doing to help
advance our understanding of the complex
mechanisms that underlie different types of
breast cancer,” said Jo Anne Zujewski, M.D.,
a senior investigator in the clinical
investigations branch at NCI.
“We hope that this model of international
collaboration is one which we can build upon
in the future."
Lapatinib, in combination with the chemotherapy
drug capecitabine, was approved by the U.S.
Food and Drug Administration in March 2007
for the treatment of advanced or metastatic
HER2-positive breast cancer in patients who
had received prior therapy with three agents
-- an anthracycline, a taxane and Herceptin.
GlaxoSmithKline is providing the study drug,
as well as additional financial support for
the ALTTO trial.
All drugs carry potential side effects, and more
information of side effects for lapatinib
and trastuzumab can be found in the Q&A at
http://www.cancer.gov/newscenter/pressreleases/ALTTOQandA.
NCI and GSK also provided comment and input
on the design of the study.
NCCTG will act as the treatment base for ALTTO in
North America. BIG is a network of 41 non-U.S.
research groups from around the world. Its
Brussels-based BrEAST Data Center is
providing centralized data management for
the global study (including the United
States).
The other members of TBCI include the Eastern
Cooperative Oncology Group (ECOG), the
Cancer and Leukemia Group B (CALGB), the
Southwest Oncology Group (SWOG), the
American College of Surgeons Oncology Group
(ACOSOG), and the National Cancer Institute
of Canada Clinical Trials Group (NCIC CTG).
To date, more than 300 centers around the world
have enrolled patients into ALTTO. Full
enrollment is expected to involve about 500
centers in the United States and more than
800 centers in Europe and the rest of the
world. A complete listing of ALTTO
participating sites can be found by
searching for ALTTO at
http://clinicaltrials.gov.
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