The Next Generation of Breast Cancer Prevention:
Clinical Trial Background for NSABP P-4
The Study to Evaluate Letrozole and Raloxifene (STELLAR), or NSABP P-4, is a clinical trial that represents an opportunity to dramatically reduce the toll of breast cancer. With 175,000 women diagnosed with invasive beast cancer each year – and 40,000 women dying each year from the disease – NSABP P-4 is designed to evaluate the efficacy of letrozole, a drug that shows the potential to reduce breast cancer incidence by more than 70%.
NSABP P-4 Review and Approval Process To-Date
NSABP submitted the NSABP P-4 study concept to the NCI’s Division of Cancer Prevention.
The NCI’s Executive Committee reviewed and approved the NSABP P-4 study proposal.
The NCI’s Clinical Trials Operations Committee (CTOC) and a Special Emphasis Panel approved the trial proposal.
The NCI’s Division of Cancer Prevention conditionally approved the full NSABP P-4 protocol, pending review by the U.S. FDA.
Full competitive renewal of the NSABP Community Clinical Oncology Program (CCOP) Research Base award (which included the P-4 study) underwent peer review at the NCI and was awarded a priority score of 131 – the best grant proposal score in the nearly 50- year history of NSABP. A Special Emphasis Panel recommended that the NSABP receive approximately $66 million in direct funding over a five-year period for NSABP P-4, with $12.3 million recommended for Year 1.
The U.S. FDA provided approval for the NSABP to proceed with the NSABP P-4 trial.
The NCI’s Executive Committee issued the agency’s final approval to proceed with the trial on the 22nd. The following day, NCI Director Niederhuber placed the study on hold and continues to delay commencement of the trial.
Dr. Niederhuber convened an ad hoc expert panel to further discuss the P-4 trial in an unusual, closed-door session. The same month, prior to the ad hoc panel meeting, Dr. Niederhuber indicated in an interview with the Cancer Letter “it is unlikely that the trial would open this year, if at all.”Health Canada provided approval for the NSABP to proceed with the NSABP P 4 trial at sites located throughout Canada.
The report of the ad hoc panel was presented to the NCI National Cancer Advisory Board (NCAB) on Thursday, June 14th. Dr. Niederhuber issued his decision on Tuesday, June 19th stating that “the NCI will not commit to the funding of this particular trial.”
The NSABP P-4 Trial
NSABP Heritage of Breast Cancer Treatment and Prevention