In a recently issued statement, Frances M. Visco, president of the National Breast Cancer Coalition (NBCC), commended Genentech for partnering with breast cancer advocates in all aspects of the HER-2 clinical trial. “It is clear that we will only
In a recently issued statement, Frances M. Visco, president of the National Breast Cancer Coalition (NBCC), commended Genentech for partnering with breast cancer advocates in all aspects of the HER-2 clinical trial. It is clear that we will only reach our goal of eradicating breast cancer if advocates, industry, and the scientific community can work together to find the solution. The National Breast Cancer Coalition is proud to have been a part of this new model of cancer research, said Ms. Visco.
The NBCC president also thanked the women with breast cancer who participated in this trial, noting that without their willingness to be a part of this research, we would never move forward in our mission to eradicate breast cancer.
The recent FDA approval of trastuzumab (Herceptin), the first monoclonal antibody treatment for metastatic breast cancer, represents many breakthroughs, according to Ms. Visco. First, it encourages critically needed new directions in breast cancer research. Second, it is an excellent illustration of the speed and efficiency with which breast cancer treatments designated as fast track products can gain FDA approval. And perhaps most importantly, the development of Herceptin provided an invaluable model of a successful partnership between breast cancer advocates and industry.
Clinical Trials Project Aimed at Fast-Tracking Breast Cancer Clinical Research
Ms. Visco described the NBCCs clinical trials project. Launched in 1996, this four-pronged strategy is aimed at moving clinical research in breast cancer to a fast track, without compromising scientific integrity.
Through its legislative component, NBCC lobbies for laws that will ensure support for clinical trials; through education, we make certain our members understand the importance of trials and how to analyze trial information; our clearinghouse will give the public information about trials in lay terms, Ms. Visco said. The industry partnership component of this program is meant to ensure collaboration between consumer advocates, scientists and industry, to design, implement and oversee specific clinical trials in breast cancer, she added.
Ms. Visco noted that Genentech was the first pharmaceutical company that agreed to partner with advocates. She characterized this pilot of NBCCs clinical trials project as extremely successful.
Genentech worked with us on all aspects of the trial, from protocol design, to outreach, to oversight. In particular, the companys agreeing to our request that investigators in specific communities partner with trained activists in facilitating accrual to the trial helped lead to record accrual, said Ms. Visco.
Need to Improve Adult Enrollment in Cancer Clinical Trials
According to Ms. Visco, fewer than 3% of adult cancer patients in the United States are presently enrolled in clinical trials. She warned that if that number does not increase dramatically in the near future, efforts to cure or prevent this disease may be in jeopardy. Without clinical trials, without new models of research, we will never know if the stunning results in animals that have recently been in the news will have any meaning for human beings, which is of course the goal.
As there are more and more laboratory discoveries in cancer, the new model of research established by the NBCC/Genentech collaboration will be essential to progress, Ms. Visco asserted. The National Breast Cancer Coalition applauds Genentech, and the investigators who worked with advocates on this trial. We invite representatives of industry and the scientific community to accept this new model and to collaborate with NBCC on breast cancer clinical trials.