Cincinnati--The University of Cincinnati (UC) Barrett Cancer Center
is participating in a new phase III clinical trial launched by the
National Surgical Adjuvant Breast and Bowel Project (NSABP), a network
of medical professionals funded by the National Cancer Institute (NCI).
The study, Protocol B-31, will evaluate Herceptin as a breast cancer
treatment to be used with traditional chemotherapy and Taxol. At more
than 100 sites across the United States and Canada, Protocol B-31 will
assess the safety and efficacy of the combination of Herceptin and
chemotherapy in the treatment of 2,700 breast cancer patients who have
cancer cells found in the lymph nodes and whose tumors overexpress the
HER2 (human epidermal growth factor receptor-2) protein.
gene (also referred to as erbB-2 or HER2/ neu) produces a protein that
stimulates normal cell growth. It also seems to play a significant role
in the biology of breast cancer. An abundance of the HER2 protein is
found in about 25-30 percent of malignant breast tumors and is
associated with more aggressive cancer growth and shorter patient
survival. Based on this knowledge, researchers are now testing
therapies that are aimed at tumors with HER2.
"Herceptin is on
the forefront of biologic warfare against breast cancer and UC is
excited to be on the frontline bringing these potential advancements to
the women of the Tristate area," said Elizabeth Shaughnessy, MD,
principal investigator, assistant professor, UC Department of Surgery.
"The results of this study may improve treatment for women with early
stage breast cancer tumors that overexpress HER2 and we look towards
the future with anticipation."
Herceptin, a humanized monoclonal
antibody, was approved by the U.S. Food and Drug Administration (FDA)
to treat women with metastatic breast cancer with HER2-associated
tumors. In a previous clinical trial, women with HER2 positive
metastatic breast cancer who received Herceptin in combination with
chemotherapy achieved a 50 percent response rate compared to 32 percent
for women receiving chemotherapy alone. These women who received
Herceptin in addition to chemotherapy lived longer than those who
received chemotherapy alone. Few therapies have demonstrated such a
survival benefit in this patient population. In the the new trial, the
role of Herceptin will be tested in women with breast cancers having
HER2 overexpression and whose tumors have spread to the underarm lymph
nodes but not to other organs. They will be given either chemotherapy
alone, or chemotherapy plus Herceptin.
Side effects most commonly
associated with Herceptin include fever and chills, infusion-related
reactions that are generally treatable. In some patients, previous
research has shown that Herceptin alone, or in combination with
standard chemotherapy, can increase a patient's risk for developing
serious heart problems. As a result, B-31 was designed to closely
monitor patients for serious heart problems.
NSABP Protocol B-31
will be conducted in two stages. Stage 1 will evaluate 1,000 patients
for cardiac safety and compare the toxicities of adding weekly
Herceptin to chemo treatments with Taxol, Adriamycin, and
cyclophosphamide. If researchers determine the potential benefits of
Herceptin therapy are greater than the drug-related side effects, the
study will proceed to Stage 2. This second stage will accrue an
additional 1,700 patients to study the efficacy of adding Herceptin to
the standard chemotherapy regimen followed by Taxol in prolonging
patient survival and disease-free survival.
In women with
metastatic breast cancer, Herceptin may also be associated with
increased shortness of breath, or problems breathing. Rarely, these
reactions can be severe or life threatening. Patients with pre-existing
lung disease or breast cancer that has spread to their lungs may be
more susceptible to these reactions. Since B-31 is designed to evaluate
the potential safety and efficacy of Herceptin in women with early
stage breast cancer, these pulmonary reactions are rare. Women with
existing heart disease are not eligible to participate.
was discovered and developed and is manufactured and marketed in the
U.S. by Genentech. It is currently indicated as a first line therapy in
combination with Taxol and alone as a second and third line therapy for
women with metastatic breast cancer who have tumors that overexpress
the HER2 protein. For more information on protocol B-31, please call
the UC Barrett Cancer Center at 513/584-2951. Or, call the NCI Cancer
Information Service at 1-800-4-CANCER (1-800-422-6237) to locate a
participating site near you. Additional information can be obtained by
visiting the NSABP Web site at http://www.nsabp.pitt.edu or NCI
clinical trials Web site at http://cancertrials.nci.nih.gov.