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
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.