The Biology of ERNegative Breast Cancer In Various Racial

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The Biology of ER-Negative Breast Cancer In
Various Racial Ethnic Groups
RFA-CA-09-026

• NCI Contact
• Neeraja Sathyamoorthy, PhD
• Program Director
• Division of Cancer Biology
• National Cancer Institute

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• Specific Questions?
• Email sathyamn_at_mail.nih.gov

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Purpose of the Teleconference

• Objectives of the RFA
• Key areas of research priorities
• Response to FAQs

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Rationale for the RFA

• To stimulate research into the basic
• biology of ER-negative breast cancer in
• various racial and ethnic groups

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RFA Scientific Goals
Systematic Study of the Biology of ER-Negative
Human Breast Cancer

• Basic biology of ER-negative breast cancers
• Differences between ER ER- tumors
• Heterogeneity within ER- breast cancers
• Differences in ER- breast cancers among racial
  ethnic groups
• Emphasis on Human Breast Cancer

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Scientific Questions

• Molecular characteristics of ER vs ER- tumors
• Key genes that are altered in ER and ER- tumors
  
• - genetic and/or epigenetic alterations
• Signaling pathways unique to ER- tumors
• Subtypes present within ER- tumors

Merely examples not an all-inclusive list
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Scientific Questions (cont.)

• Identify progenitor cells that give rise to ER-
  tumors
• Determine whether ER- phenotype is evident in
  pre-malignant lesions
• Define role of tumor-associated stroma in
  contributing to ER- tumor progression
• Understand the molecular basis for racial and
  ethnic differences

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Responsive/Non-Responsive Applications

• Responsive
• Use of human samples
• Experimental models relevant to human ER- breast
  cancer
• Comparison of ER and ER- human breast cancers
• Comparison of ER- human breast cancer among
  ethnic groups
• Non-Responsive
• Exclusive use of
• - human breast cancer cell lines
• - animal models or non-human tumor samples

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Cooperative Agreement (U01)

• PIs Role Responsibility
• Plan direct research program
• Provide Multi-PI leadership plan
• Roles/areas of responsibility of the PIs
• Fiscal management coordination
• Process for making decisions on scientific
  direction allocation of resources
• Data sharing
• Communication among investigators
• Publication intellectual property (if needed)
  policies
• Procedure for resolving conflicts
• http//grants.nih.gov/grants/multi_pi/sample_leade
  rship_plans.pdf

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Cooperative Agreement (UO1)

• PIs expected to
• Attend annual meeting
• Share scientific information
• Participate in occasional teleconferences

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Page Limit 25 pages

• Specific Aims
• Background Significance
• Preliminary Studies
• Research Design Methods
• Does not include
• Multi-PI Leadership Plan
• Information on Animal use/Human Subjects
• Support Letters
• References

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U01 Budget

• Total Cost 667,000
• Direct Cost
• Consortium Cost
• Indirect Cost

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Review Considerations

• Standard Review Criteria
• Clinical relevance
• Feasibility
• Expertise
• Statistical input
• Multi-PI related issues

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Scoring Descriptions
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Dates to Remember

• Pre-application Teleconference
• Sept 28, 2009, 2-3 pm EST
• Letters of Intent Dec 5, 2009
• Application Receipt Jan 5, 2010
• Peer Review May 2010
• Council Review Sept 2010
• Anticipated Start Date Sept 2010

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• Contact Information
• Neeraja Sathyamoorthy, PhD
• Division of Cancer Biology
• National Cancer Institute
• 301-435-1878
• sathyamn_at_mail.nih.gov

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Questions

• Can one use ER- samples alone? Is it necessary to
  use both ER as well as ER- samples?
• Is it OK to obtain samples from outside the
  U.S.?
• Is the racial ethnic component essential for
  all grant applications?