07-1408. National Cancer Institute; Notice of Closed Meeting

The National Cancer Advisory Board's Breast Cancer Prevention Trail P-4 Working Group will meet to discuss the P-4 trial which is designed to perform a 10-year study in risk-eligible, postmenopausal women to determine whether letrozole is more effective than raloxifene in reducing the incidence of invasive breast cancer in this otherwise healthy population. The meeting will be closed to the public.

The thoughts and input from this meeting will be summarized in a report that will be presented to the National Cancer Advisory Board in open session at an upcoming meeting.

Name of Work Group: National Cancer Advisory Board, Breast Cancer Prevention Trial P-4 Working Group.

Closed: March 23, 2007, 8:30 a.m. to 4:30 p.m.

Agenda: The purpose of the Work Group will be to ensure that funds are invested optimally to achieve outcomes that utilize the best of clinical and molecular sciences to answer key scientific questions, produce extremely valuable data sets for the community, and, in this instance, provide maximal benefit to breast cancer patients.

Place: Hyatt Regency Building, One Metro Center, Bethesda, MD 20814.

Contact Person: Dr. Paulette S. Gray, Executive Secretary, National Cancer Advisory Board, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327, [phone].

SUPPLEMENTARY INFORMATION:

Background

Over the past several years the National Cancer Institute has performed a series of important prevention clinical trials to study the effects) of tamoxifen, raloxifene (Selective Estrogen Receptor Modulators—SERMS) and, subsequently, aromatase inhibitors such as letrozole on reducing the incidence of invasive breast cancer in defined populations of postmenopausal women. As follow-on to this series of breast cancer prevention trials, a new trial in the sequence, the P-4 trial, has been proposed and peer-reviewed. The P-4 trial is designed to perform a 10-year study in risk-eligible, postmenopausal women to determine whether letrozole is more effective than raloxifene in reducing the incidence of invasive breast cancer in this otherwise healthy population. The trial will accrue 12,800 patients over 4 years. The primary endpoint for this trial will be the first occurrence of invasive breast cancer. Secondary endpoints will include DCIS; LCIS; ischemic heart disease; fracture of the wrist, hip, and spine; DVTs; PEs; TIAs and stroke; death; other invasive cancers; and quality of life.

P-4 trial is a significant financial commitment on the part of the National Cancer Institute and of the cancer research community. Additionally, the outcome of this trail will require more than 10 years of study. Given the magnitude of this investment, the rapid acceleration of progress in molecular genetics and molecular biology, and the disparate range of views on the trial, the National Cancer Advisory Board is convening a group of experts to provide feedback to the National Cancer Advisory Board.

Any interested person may file written comments with the work group by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

(Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)

Dated: March 16, 2007.

Anna Snouffer,

Acting Director, Office of Federal Advisory Committee Policy.