oncologists across the nation want to know whether a certain drug
combination can slow the progression of male breast cancer, a rare
disease that often goes undiagnosed until it’s in an advanced stage.
Nahleh, MD, director of breast oncology in the University of
Cincinnati’s (UC) division of hematology and oncology, is leading a
national phase-2 clinical trial to test whether the drug anastrozole
(Arimidex), currently approved by the Food and Drug Administration
(FDA) for treating breast cancer in postmenopausal women, can
effectively fight the same disease in men.
we’re going to make significant advances against the disease,” says
Nahleh, “we need better male-specific treatment strategies.”
research has shown that the female hormone estrogen promotes the growth
of certain types of breast cancer. Anastrozole is one of a class of
drugs, known as non-steroidal aromatase inhibitors, that block the
tumor’s use of estrogen and slow its development.
treating male breast cancer with a combination of anastrozole and a
synthetic hormone called goserelin, Nahleh believes physicians may be
able to stop the transition of the male hormone testosterone to the
estrogen estradiol, significantly lowering the man’s overall estrogen
levels and limiting breast tumor growth.
Goserelin is what is known as a gonadotropin-releasing hormone, which stops
testosterone production in men and decreases estradiol in women. It
already has FDA approval for the treatment of prostate cancer,
endometriosis and advanced premenopausal and perimenopausal breast
biology of breast cancer is different in men and women, so identical
treatment methods are not the best solution,” explains Nahleh. “We
believe that anastrozole—when used in conjunction with a
gonadotropin-releasing hormone injection—will lower the amount of male
estrogen in the body, resulting in better control of the breast tumor.”
trial, sponsored by the National Cancer Institute and Southwest
Oncology Group, is the first to test this specific drug combination in
men with advanced breast cancer.
seen a 26 percent increase in the number of male breast cancer cases
since 1973, but the disease is so rare that there’s been little
research to determine the best ways to detect and treat the disease
specifically in men,” explains Nahleh.
male breast cancer treatment methods are based on accepted approaches
to the disease in women. Unlike female breast cancer, says Nahleh, the
relationship between the estrogen receptor and overall survival in men
is uncertain. In addition, mortality from the disease has not declined as it has in women.
Nahleh’s direction, researchers from 53 medical centers nationwide will
test the drug combination on about 60 male patients—age 18 or older—who
have recurrent or advanced breast cancer.
will receive an anastrozole pill every day and a goserelin injection on
the first day of 12, month-long cycles. Every two months researchers
will collect serum samples to evaluate blood estrogen levels. They will
also obtain CAT scan and X-ray images of the tumor to determine how the
patient is responding.
the treatment, Nahleh and her team will follow patients for three years
to determine whether the approach is a sustainable option for managing
male breast cancer.
American Cancer Society estimates that more than 1,700 men will be
diagnosed with breast cancer in 2006 and about 27 percent will die from