MGH leading international trial of
novel breast cancer drug
TEACH study is phase III trial of
new targeted drug Tykerb for HER2-positive tumors
BOSTON - December 11, 2006 - A clinical trial of a new targeted
breast cancer drug, led by physicians at Massachusetts
General Hospital (MGH) Cancer Center, has begun enrolling patients.
The TEACH (Tykerb Evaluation After CHemotherapy) trial will investigate
the experimental drug Tykerb (lapatinib) in patients with early-stage,
HER2-positive breast cancer who have not been treated with Herceptin,
another targeted drug used for the same type of tumor. The MGH is
the lead institution for the international trial, which is being
sponsored by GlaxoSmithKline, the manufacturer of Tykerb.
"This trial represents another step toward understanding the
role of targeted therapies in extending disease-free survival,"
said Paul Goss, MD, PhD, director of Breast Cancer Research at the
MGH Cancer Center, who proposed the TEACH study and chairs the International
About one quarter of breast cancer patients have tumors that overexpress
or produce too many copies of a receptor molecule called HER2. Because
cellular growth is stimulated by the overactivity of this molecule,
which also is called ErbB2, these tumors are more likely to recur
and are less responsive to hormone-based treatments. Herceptin,
a monoclonal antibody that blocks the HER2 receptor, is approved
by the FDA as an adjuvant treatment - given along with chemotherapy
after surgical removal and/or radiation therapy - for early-stage,
node-positive and HER2-positive tumors as well as for metastatic
Tykerb blocks both the HER2/ErbB2 receptor and a related molecule
called ErbB1. Earlier clinical trials have indicated that it may
have advantages over Herceptin in a number of settings related to
treatment of HER2-positive breast cancer without significant side
effects. Tykerb has not yet received approval from the U.S. Food
and Drug Administration, and the TEACH study is a Phase III trial
of its use in patients with early-stage HER2-positive tumors. To
enroll in the study - which is being conducted at 450 sites around
the world - patients must have completed adjuvant chemotherapy but
not have received Herceptin. Study participants will be randomized
to receive a daily oral dose of either Tykerb or a placebo for up
to one year.
"The TEACH study will be the first to investigate the use of
a dual ErbB1 and ErbB2 inhibitor as an adjuvant treatment for women
with HER2-positive breast cancer, who are at a high risk of their
disease recurring," says Goss.
"The concept of the TEACH study arose from our clinics,"
says Beverly Moy, MD, a medical oncologist at the MGH Breast Center
and a member of the TEACH International Steering Committee."We
have patients with HER2-positive breast cancer who had never received
Herceptin because they were diagnosed before we knew about the benefits
of Herceptin in early-stage breast cancer. The results of this study
could reveal whether the targeted therapy Tykerb could benefit women
several years after the initial diagnosis of breast cancer."
U.S. patients interested in enrolling in the TEACH trial should
call toll-free (877) 379-3718. Those
interested in enrolling at the MGH can call (617) 643-3555. Additional
information on the study is available at the National Institute
of Health's ClinicalTrials.gov
An integral part of one of the world's most distinguished medical
centers, the Massachusetts General Hospital Cancer Center is chosen
by more cancer patients than any other hospital in New England.
Known for providing individualized, compassionate care to both adults
and children, the MGH Cancer Center is comprised of 16 fully integrated,
multidisciplinary clinical programs and a vast network of support
and educational services. Scientific investigations are conducted
as part of the largest hospital-based research program in the United
States, and a powerful synergy between physicians and laboratory
scientists fosters innovation in basic, translational and clinical
research. The MGH is consistently ranked as one of the best cancer
treatment centers in the country by US News and World Report,
and MGH nurses were the first in the state to achieve Magnet status
for exceptional nursing care.
Media Contact: Valerie
Wencis , MGH Public Affairs
Physician Referral Service: 1-800-388-4644
Information about Clinical Trials