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283 Development of a Molecular Diagnostic Assay to Detect Basal-like Breast Cancer

(Fast-Track proposals will not be accepted. Phase II information is provided only for informational purposes to assist Phase I offerors with their long-term strategic planning.)

Number of anticipated awards: 2

Budget (total costs): Phase I: $150,000 for 9 months;
Phase II: $1,000,000 for 2 years

It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 8, 2010 by 5 p.m. EST.

Breast cancer is a heterogeneous disease with a number of distinct biological entities that are associated with specific morphological/immune-histochemical features and clinical behavior. Basal-like breast cancer is one of the five intrinsic subtypes, which was classified by gene expression profiling in breast cancer. The four other subtypes include luminal A, luminal B, human epidermal growth factor receptor-2 (HER2) over expressing, and normal-like. 15-20% of breast cancer patients have basal-like subtype, which is the most aggressive subtype in breast cancer. It is associated with high grade, poor prognosis, and younger patient age. Population-based study has shown that this subtype is more prevalent in premenopausal African American women, which may contribute to the poor outcomes seen among these patients. Currently there is no effective assay product with low cost to detect the basal-like subtype in the market. The purpose of this initiative is to provide support for the development of a molecular diagnostic assay to detect basal-like breast cancer. The selected proposers will develop an assay for detection of basal-like subtype at the cell, protein, or DNA level. This will enable basal-like breast cancer to be identified specifically. The final assay should enable tests to be completed within one day at a low cost. In Phase I, the development of molecular diagnostic assay should focus on proof-of-concept. In Phase II, the assay developed in Phase I will be validated under a plan developed in consultation with the NCI project officer.

Project Goals:
The goal of the project is to develop a molecular diagnostic assay to detect basal-like breast cancer with sensitivity and specificity that is able to distinguish basal-like breast cancer from other subtypes in both human cells and tissues. The assay can be used for early detection of basal-like breast cancer, or be used as post-treatment monitoring to detect recurrence of the cancer. The assay may also be used to provide a better mechanistic understanding of basal-like tumor development, so the knowledge can help develop preventive, diagnostic, or therapeutic agents that target specifically against basal-like subtype and further improve patient outcome. The assay development should be platform driven, meaning that the procedure for the assay development should be easily applied for a new assay development for the detection of other cancer subtypes in breast cancer or other cancer types such as prostate or colon cancers.

Phase I activities and expected deliverables:
  • Identification and validation of a set of markers for the detection of basal like breast cancer.
  • Develop an assay to identify these markers effectively and distinguish basal-like subtype from other subtypes in breast cancer with cell lines and/or tissues.
  • Demonstration of high reproducibility and accuracy with blinded samples from cell lines and/or tissues.
  • Demonstration of high specificity and sensitivity of the assay when compared to other subtypes.
  • Deliver to NCI the SOPs of the molecular diagnostic assay for basal-like breast cancer.

Phase II activities and expected deliverables:
  • Demonstration of the assay that enables a test to be finished within one day.
  • Perform studies to characterize the assay in animal models with different subtypes of breast cancer.
  • Validation of high throughput screening assays with primary cells and/or tissues obtained from patients.
  • Demonstration of platform capability that enables the procedure of the assay development to be easily applied to new assay development for the detection of other subtypes of breast cancer or other cancer types/subtypes.
  • Validation of the assay in the clinical setting.
  • Submission of regulatory application to obtain necessary approval for clinical validation.

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