UNIVERSITY OF MIAMI
This grant addresses broad Challenge Area (04) Clinical Research, and specific Challenge topic 04-GM-101: Personalized drug response and toxicity. The Challenge and Potential Impact: With a global incidence of 1,151,298 each year, breast cancer is the most frequently diagnosed cancer and the second leading cause of cancer death (465,000/year) in women. Triple-negative breast cancer (TNBC), defined by lack of expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2), accounts for 15-20% of all breast cancers and is associated with poor clinical outcome, in part due to the lack of available targeted treatments. Currently, there is no consensus regarding optimal chemotherapy regimens for the treatment of such patients. Preclinical data suggests that TNBC may be sensitive to platinum-based chemotherapy because of deficiencies in BRCA-associated DNA repair, especially defective homologous recombination. We therefore hypothesize that gene expression changes will be identified in locally advanced triple negative breast cancer patients which are associated with pathological and/or clinical complete response to platinum-based chemotherapy. The aim of this study is to evaluate gene expression profiles and/or copy number variation associated with pathologic (pCR) and clinical complete response (cCR), in patients with TNBC treated with neoadjuvant platinum-based chemotherapy, in order to identify robust biomarkers for response prediction. In order to test our hypothesis, we will complete the following specific aims: Aim I: Identify genome-wide differences in gene expression between pathological complete responders and non-responders in locally advanced triple negative BC samples. Aim 2: Identify genome-wide differences in gene expression between clinical complete responders and nonresponders among locally advanced triple negative BC samples from patients which do not exhibit pCR. Aim 3: Investigate possible chromosomal alterations associated with gene expression differences. The use of expression array technology historically has been dependent upon the availability of intact RNA from fresh frozen tumor tissue for analysis, thus study of the many large retrospective cohorts with annotated clinical follow-up has not been possible. However, using an innovative approach we have recently successfully tested novel array probes specifically designed to detect partially degraded RNA.
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| AWARD OVERVIEW |
| Award Number |
1RC1CA147163-01 |
Funding Agency |
Department of Health and Human Services |
| Total Award Amount |
$996,077 |
Project Location - City |
Miami |
| Award Date |
09/30/2009 |
Project Location - State |
FL |
| Project Status |
Completed |
Project Location - Zip |
33136-1000
|
| Jobs Reported |
0.00 |
Congressional District |
18 |
| Project Location - Country |
US |
|
|
Recipient Information
(Grants)
| Recipient Information (Grants) |
|
Recipient Name
|
UNIVERSITY OF MIAMI |
| Recipient DUNS Number |
052780918
|
| Recipient Address |
1400 NW 10 AVE RM 1007P |
| Recipient City |
MIAMI |
| Recipient State |
Florida |
| Recipient Zip |
33136-1002 |
| Recipient Congressional District |
18 |
| Recipient Country |
USA |
Required to Report Top 5
Highly Compensated Officials |
No |
Projects and Jobs Information
| Projects and Jobs Information |
| Project Title |
MOLECULAR ANALYSIS OF NEOADJUVANT PLATINUM IN TRIPLE NEGATIVE BREAST CANCER |
| Project Status |
Completed |
| Final Project Report Submitted |
Yes |
| Project Activities Description |
Research & Public Policy Analysis |
| Quarterly Activities/Project Description |
Patients and Methods: This is a retrospective study of one hundred forty four women with TNBC treated with neoadjuvant platinum containing chemotherapy for locally advanced breast cancer at the University of Miami between January 1, 1999 and January 1, 2011. The medical record was reviewed to obtain data on clinical characteristics, including ethnicity, race, age, clinical stage, treatment regimen and vital status. Tissue blocks were obtained for genetic microarray. This study was approved by the University of Miami IRB.
Results: All patients had locally advanced breast cancer with at least one of the following features at presentation: T3, T4, N2, N3. The mean tumor size by palpation was 9.4 cm. The clinical T stage at presentation was: 1.4% T1. 8.3% T2, 52.8% T3, 37.5% T4 (19.4% T4d). The nodal status by physical exam at presentation was: 23% N0, 37.5% N1, 34% N2, and 5.5% N3. pCR in breast and axilla was seen in 31%. PFS and OS was 55% and 59% at 7 years. Cisplatin offered a survival advantage over carboplatin in both PFS (p=0.007) and OS (p=0.018). Node positivity was the most important predictor of survival. A distinct genetic profile was seen in the patients that achieved a pCR.
Conclusion: Cisplatin/docetaxel neoadjuvant therapy was well tolerated and effective therapy in locally advanced TNB. The responders had a distinctive genetic signature based on microarray profile.
During Q2 2012 vendor payments greater than $25k were incorrectly included in the vendor payments less than $25k. Vendor payments less than $25k are correctly reported this quarter but last quarter they were overstated by:
Total Number of Payments: 2
Total Amount of Payments: $218,300
Vendor payments greater than $25k were correctly reported.
|
| Jobs Created |
0.00 |
| Description of Jobs Created |
No jobs were funded this quarter. |
Purchaser Information
(Grants)
| Purchaser Information |
| Contracting Office ID |
Not Reported |
| Contracting Office Name |
Not Available |
| Contracting Office Region |
Not Available |
| TAS Major Program |
75-0850 |
| Award Information |
| Award Date |
09/30/2009 |
| Award Number |
1RC1CA147163-01 |
| Order Number |
|
| Award Type |
Grants |
| Funding Agency ID |
75 |
| Funding Agency Name |
Department of Health and Human Services |
| Funding Office Name |
Not Available |
| Awarding Agency ID |
75 |
| Awarding Agency Name |
Department of Health and Human Services |
| Amount of Award |
$996,077 |
| Funds Invoiced/Received |
$881,587 |
| Expenditure Amount |
$881,587 |
| Infrastructure Expenditure Amount |
$0 |
| Infrastructure Purpose and Rationale |
N/A |
| Infrastructure Point of Contact Name |
Not Reported |
| Infrastructure Point of Contact Email |
Not Reported |
| Infrastructure Point of Contact Phone |
Not Reported |
| Infrastructure Point of Contact Address |
Not Reported |
| Infrastructure Point of Contact City |
Not Reported |
| Infrastructure Point of Contact State |
Not Reported |
| Infrastructure Point of Contact Zip |
Not Reported |
Product or Service Information
(Grants)
| Product or Service Information |
| Primary Activity Code |
**K |
| Activity Description |
Research & Public Policy Analysis |
| Sub-Awards Information |
| Sub-awards to Organizations |
0 |
| Sub-award Amounts to Organizations |
$0 |
| Sub-Awards to Individuals |
0 |
| Sub-Award Amounts to Individuals |
$0 |
| Number of Sub-awards less than $25,000/award |
0 |
| Amount of Sub-awards less than $25,000/award |
$0 |
| Number of payments to vendors greater than $25,000 |
2 |
| Total Amount of payments to vendors greater than $25,000/award |
$218,300 |
| Number of payments to vendors less than $25,000/award |
107 |
| Total Amount of payments to vendors less than $25,000/award |
$24,154 |
Almac Diagnostics Incorporated - Award Number 1RC1CA147163-01 - Almac Diagnostics Incorporated
| Award Number |
1RC1CA147163-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
795791735 |
| Vendor HQ Zip Code + 4 |
27713-4384 |
| Vendor Name |
Almac Diagnostics Incorporated |
| Product and Service Description |
Research and Science Based Services |
| Payment Amount |
$85,000 |
Almac Diagnostics Incorporated - Award Number 1RC1CA147163-01 - Almac Diagnostics Incorporated
| Award Number |
1RC1CA147163-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
795791735 |
| Vendor HQ Zip Code + 4 |
27713-4384 |
| Vendor Name |
Almac Diagnostics Incorporated |
| Product and Service Description |
Research and Science Based Services |
| Payment Amount |
$133,300 |
| Location Information |
| Latitude, Longitude |
25º 47' 19",
-80º 12' 39" |
| Congressional District |
18 |
| Address 1 |
|
| Address 2 |
|
| City |
Miami |
| County |
Miami-Dade |
| State |
FL |
| Zip |
33136-1000 |
|
 |