Breast Cancer: Coalition of Cancer Cooperative Groups Identifies Highest-Priority Phase III Trials

A panel of 21 experts from the Coalition of Cancer Cooperative Groups' Scientific Leadership Council in Breast Cancer has prioritized 13 specific Phase III breast cancer trials from the 515 currently underway as being those with the greatest potential to improve treatment and survival.

The consensus was reached at a meeting of physicians, researchers, patient advocates, and government and industry representatives last month in Dallas, and the group urged physicians to enroll as many of their eligible patients into the trials as possible.

The Council was co-chaired by Julie Gralow, MD, Director of Breast Medical Oncology at the Univesity of Washington Seattle Cancer Care Alliance, and Edith Perez, MD, Director of the Breast Cancer Program and Department of Internal Medicine at the Mayo Clinic in Jacksonville, Florida.

A news release from the Coalition notes that although the priority studies together require patient enrollment of nearly 43,500, only about 17,400 patients have been enrolled to date.

Enrollment of breast cancer patients in publicly funded studies averages about 9,300 annually, according to a 2006 study by the Coalition; the number of breast cancer patients on privately funded studies is not known.

More rapid enrollment and timely completion of these studies can quicken the pace of diagnostic and treatment advances by resolving such important questions as the following, the panel said:

* How to predict the impact of biological effects of chemopreventive agents with the development and validation of new, clinically relevant biomarkers.

* How to design, select, and afford individualized cancer therapy in an era of escalating costs for biologic treatments.

* How, when, and whether to use chemotherapy in breast cancer treatment for some patients.

* How to best incorporate novel approaches, including biophosphonates, in breast cancer treatment to reduce the risk of bone metastases.

* How best to address the growing issue of long term neurotoxic and cognitive side effects in breast cancer survivors.

* How to design clinical trials that can be completed more efficiently, including randomized discontinuation trials or adaptive trial designs that require fewer patients and/or shorter study duration.

Six of the studies are for patients with early-stage breast cancer, three are studies investigating the use of drugs to shrink tumors or eliminate cancer cells prior to surgery, two are in advanced breast cancer, one focuses on quality of life, and one on the effectiveness of partial- vs whole-breast irradiation.

Table High-Priority ...

In addition, a molecular/genetic profiling study will determine whether some women typically treated with chemotherapy in addition to hormonal therapy based on clinical characteristics may not need chemotherapy.

The panel also emphasized the importance of connecting patients to information about clinical trials, noting that research conducted by the Coalition and Northwestern University shows that at the time of diagnosis only 15% of all breast cancer patients are aware of the possibility of enrolling in a clinical trial.

TrialCheck (CancerTrialsHelp.org), the Coalition's user-friendly online system, which includes all federally registered cancer studies, electronically links patients to hospitals and practices near their home offering cancer clinical trials relevant to the patient's individual medical needs. TrialCheck won a Consumer Health World Award this year, which is given to recognize excellence and advancement in health and wellness that enhances consumers' ability to better manage their health care expenditures and control their quality of life.

The full consensus report is being prepared for submission for publication in a peer-reviewed journal. A similar document about colorectal cancer research priorities was published in the June 1, 2007 issue of the Journal of Clinical Oncology.