[Federal Register Volume 72, Number 55 (Thursday, March 22, 2007)]
[Notices]
[Page 13502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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, (301) 496-5147.

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.
[FR Doc. 07-1408 Filed 3-21-07; 8:45 am]
BILLING CODE 4140-01-M