In about 30% of U.S. women who receive a diagnosis of early breast cancer, the cancer will progress to metastatic disease, but in the developing world, most cancer is initially diagnosed at an advanced stage, said William Gradishar, MD, director of medical breast oncology at the Robert H. Lurie Comprehensive Cancer Center, at Northwestern University, Chicago.
Unfortunately, the increasing number of MBC trials has not been accompanied by a comparable increase in enrollment. For the 80% of trials that become delayed, poor enrollment is the chief cause. This has created a “crisis in drug development,” Dr. Gradishar said. “Unless we involve patients in trials, we are not likely to make expedient progress with new therapies.”
According to BRIDGE results, 26% of the respondents had searched for information on clinical trials, 23% had been invited to participate, and 18% had actually enrolled. The principal reason for not enrolling was lack of invitation or recommendation by a healthcare professional.
Physician influence was the primary factor driving participation, no matter the country, reported Dr. Fallowfield during an AACR 2009 press briefing. Trial participation rates ranged from a high of 35% in Mexico to a low rate of 7% in France. When women were invited to participate in a trial, two-thirds accepted. For the one-third who declined, fear of side effects, ineligibility, and perceived lack of personal benefit were given as primary reasons.
