Oncotype DX Studies
Oncotype DX® has been developed through extensive laboratory
studies and multiple clinical studies. Studies of Oncotype DX in
additional breast cancer populations are ongoing.
Guidelines
Oncotype DX Clinical Validation Studies
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A Multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
(GHI/NSABP Study B-14)
Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson
D, Park T, Hiller W, Fisher E, Wickerham DL, Bryant J, Wolmark N.
N Engl J Med. 2004;351(27):2817-2826
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A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients.
Habel L, Shak S, Jacobs M, Capra A, Alexander C, Pho M, Baker J, Walker MG,
Watson D, Hackett J, Blick N, Greenberg D, Fehrenbacher L, Langholz B,
Quesenberry CP.
Breast Cancer Res. 2006;8(3):R25
Chemotherapy Benefit Studies
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Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
(GHI/NSABP Study B-20)
Paik S, Tang G, Shak S, Kim C, Baker J, W Kim, Cronin M, Baehner FL, Watson D,
Bryant J, Costantino J, Geyer Jr. C, Wickerham DL, Wolmark N.
J Clin Oncol. 2006;24(23):3726-3724
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Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal, node-positive, ER-positive breast cancer (S8814, INT0100).
Albain K, Barlow W, Shak S, Hortobagyi G, Livingston R, Yeh I, Ravdin P, Yoshizawa C, Baehner F, Davidson N, Sledge G, Winer E, Hudis C, Ingle J, Perez E, Pritchard K, Shepherd L, Allred C, Osborne K, Hayes D. Southwest Oncology Group and The Breast Cancer Intergroup of NA, San Antonio TX
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #10
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Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients.
Chang J, Makris A, Carolina Gutierrez M, Hilsenbeck SG, Hackett J, Jeong J, Liu
M, Baker J, Clark-Langone K, Baehner F, Sexton K, Mohsin S, Gray T, Alvarez L,
Chamness G, Osborne C, and Shak S.
Breast Cancer Res Treat. April 2007 (published online ahead of print)
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Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer.
Gianni L, Zambetti M, Clark K, Baker J, Cronin M, Wu J, Mariani G, Rodriguez J,
M Carcangiu, Watson D, Valagussa P, Rouzier R, Symmans WF, Ross JS, Hortobagyi
G, Pusztai L, Shak S.
J Clin Oncol. 2005;23(29):7265-7277
Oncotype DX Development Studies
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Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer.
Cronin M, Sangli C, Liu ML, Pho M, Dutta D, Nguyen A, Jeong J, Wu J, Clark
Langone K, Watson D.
Clin. Chem. 2007;53(6):1084 - 1091
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Measurement of gene expression in archival paraffin-embedded tissues.
Cronin M, Pho M, Dutta D, Stephans JC, Shak S, Kiefer MC, Esteban JM, Baker JB.
Am J Pathol. 2004;164(1):35-42
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Tumor gene expression and prognosis in breast cancer: Multi-gene RT-PCR assay of paraffin-embedded tissue.
Esteban J, Baker J, Cronin M, et al.
Presented at: Thirty-ninth Meeting of the American Society of Clinical
Oncology. May 31-June 3, 2003; Chicago, IL. Abstract #3416
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Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes.
Cobleigh MA, Tabesh B, Bitterman P, Baker J, Cronin M, Liu ML, Borchik R,
Mosquera JM, Walker MG, Shak S.
Clin Cancer Res. 2005;11(24 Pt 1):8623-8631
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Multi-Gene RT-PCR Assay for predicting recurrence in node-negative breast cancer patients — NSABP studies B-20 and B-14.
Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N et al.
Presented at: The Twenty Sixth Annual San Antonio Breast Cancer Symposium. December 3-December 6, 2003; San Antonio, TX. Abstract #16
Economic Studies
Oncotype DX and Adjuvant Treatment Decisions
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Prospective multi-center study of the impact of the 21-gene recurrence score assay on patient satisfaction, anxiety and decisional conflict for adjuvant breast cancer treatment selection.
Mumby PB, Lo SS, Norton J, Smerage J, Joseph K, Chew HK, Hayes D, Albain KS. Loyola University Medical Center, Maywood, IL; University of Michigan, Ann Arbor, MI; Edward Hospital, Naperville, IL; University of California, Sacramento, CA.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #1092
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A retrospective analysis of the impact of oncotype DX low recurrence score results on treatment decisions in a single academic breast cancer center.
Liang H, Brufsky AM, Lembersky BB, Rastogi P, Vogel VG. University of Pittsburgh Cancer Institute, Pittsburgh PA.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #2061
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Evaluation of practice patterns in the treatment of node-negative, hormone-receptor positive breast cancer patients with the use of the oncotype DX assay at the University of Pennsylvania.
Erb C, Fox KR, Patel M, Hook K, DeMichele A, Kaplan C, Domchek S. University of Pennsylvania, Philadelphia, PA.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #3082
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Prospective multi-center study of the impact of the 21-gene Recurrence Score (RS) assay on medical oncologist (MO) and patient (pt) adjuvant breast cancer (BC) treatment selection.
Lo SS, Norton J, Mumby PB, Smerage J, Kash J, Chew HK, Hayes D, Epstein A,
Albain KS.
Presented at: 43rd Annual Meeting of the American Society of Clinical Oncology.
June 1-5, 2007. Chicago, IL. Abstract #577
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Impact of a Commercial Reference Laboratory Test Recurrence Score on Decision Making in Early-Stage Breast Cancer.
Oratz R, Paul D, Cohn AL Sedlacek SM.
J Oncol Pract. 2007;3(4):182-186
Additional Oncotype DX Studies
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HER2 Concordance Between Central Laboratory Immunohistochemistry
& Quantitative Reverse Transcription Polymerase Chain Reaction in Intergroup Trial
E2197.
Baehner FL, Gray R, Childs B, Maddala T, Rowley S, Shak S, Davidson NE, Sledge GW, Goldstein LJ, Sparano JA, Badve S.
Presented at: the ASCO Breast Cancer Symposium. September 6, 2008; Washington,
D.C. Abstract #13
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HER2 Assessment in a Large Kaiser Permanente Case-Control Study:
Comparison of FISH and Quantitative RT-PCR Performed by Central
Laboratories.
Baehner FL, Achacoso, Maddala T, Alexander C, Shak S, Quesenberry CP, Goldstein LC, Gown AM, Habel LA
Presented at: the ASCO Breast Cancer Symposium. September 6, 2008; Washington,
D.C. Abstract #41
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Recurrence score by oncotype DX evaluated on the primary breast tumor predicts the 2-year survival after first relapse.
Bianchini G, Zambetti M, Mariani P, Moliterni A, Bianchi G, Mariani G, Fasolo A, Carcangiu ML, Valagussa P, Gianni L. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #1043
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Gene expression by standardized quantitative RT-PCR in the special histologic subtypes of estrogen receptor positive invasive breast cancer.
Baehner FL, Watson D, Ballard JT, Palmer G, Shak S. Genomic Health, Inc., Redwood City, CA.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #3028
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Prognostic utility of the 21-gene assay compared with Adjuvant! in hormone receptor (HR) positive operable breast cancer with 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): an analysis of intergroup trial E2197.
Goldstein L, Ravdin P, Gray R, Yoshizawa C, Childs B, Rowley S, Shak S, Badve S, Baehner FL, Davidson N, Sledge GW, Sparano JA. Eastern Cooperative Oncology Group, Brookline, MA; MD Anderson Cancer Center, Houston, TX; Genomic Health, Inc., Redwood City, CA; sanofi aventis, Bridgewater, NJ.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #63
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Estrogen receptor and breast cancer survival in a Kaiser permanente population-based study: comparison of quantitative reverse transcriptase polymerase chain reaction and immunohistochemistry.
Habel LA, Achacoso N, Maddala T, Alexander C, Baehner FL, Shak S, Quesenberry C, Gown AM, Goldstein LC. Kaiser Permanente, Oakland, CA; Genomic Health Inc, Redwood City, CA; PhenoPath Laboratories, Seattle, CA.
Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San
Antonio, Texas. Abstract #5029
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ER and PR assessment in ECOG 2197: Comparison of locally determined IHC with centrally determined IHC and quantitative RT-PCR.
Badve SS, Baehner FL, Gray R, Childs B, Maddala T, Liu M, Rowley S, Davidson N,
Shak S, Sledge Jr. GW, Sparano JA.
Presented at: The 2007 ASCO Breast Cancer Symposium. September 7-8, 2007. San
Francisco, California. Abstract #87
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A Kaiser-Permanente population-based study of ER and PR expression by the standard method, immunohistochemistry (IHC), compared to a new method, quantitative reverse transcription polymerase chain reaction (RT-PCR).
Baehner FL, Maddala T, Alexander C, Gown A, Goldstein LC, Achacoso NS, Shak S,
Quesenberry CP, Habel LA.
Presented at: The 2007 ASCO Breast Cancer Symposium. September 7-8, 2007. San
Francisco, California. Abstract #88
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Use of estrogen receptor (ER) expression by quantitative RT-PCR to identify an ER-negative subgroup by IHC who might benefit from hormonal therapy.
Bianchini G, Zambetti M, Pusztai L, Carcangiu M, Valagussa P, Gianni L.
Presented at: The 2007 ASCO Breast Cancer Symposium. September 7-8, 2007. San
Francisco, California. Abstract #106
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Association between the 21-Gene Recurrence Score assay (RS) and risk of loco-regional failure in node-negative, ER-positive breast cancer: Results from NSABP B-14 and NSABP B-20.
Mamounas E, Tang G, Bryant J, Paik S, Shak S, Costantino J, Watson D, Wickerham
DL, Wolmark N.
Presented at: 28th Annual San Antonio Breast Cancer Symposium. December 8-11,
2005. San Antonio, TX. Abstract #29
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Risk
Classification of breast cancer patients by the Recurrence Score assay:
Comparison to guidelines based on patient age, tumor size, and tumor grade.
Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner R, Walker M, Watson
D, Bryant J, Wolmark N.
Presented at: 27th Annual San Antonio Breast Cancer Symposium. December 8-11,
2004. San Antonio, TX. Abstract #104
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Expression of the 21 genes in the Recurrence Score assay and tamoxifen clinical benefit in the NSABP study B-14 of node-negative, estrogen receptor positive breast cancer.
Paik, et.al.
Presented at: 41st Annual Meeting of the American Society of Clinical Oncology.
May 13-17, 2005, Orlando, FL. Abstract #510
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Prognostic role of a multigene reverse transcriptase-PCR assay in patients with node-negative breast cancer not receiving adjuvant systemic therapy.
Esteva, et.al.
Clin Cancer Res. 2005;11(9):3315-3319
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Prognostic utility of the 21-gene assay in hormone receptor (HR) positive operable breast cancer and 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): An analysis of intergroup trial E2197.
Goldstein LJ, Gray R, Childs B, Watson D, Rowley S, Shak S, Badve S, Davidson
NE, Sledge GW, Sparano JA.
Presented at: 43rd Annual Meeting of the American Society of Clinical Oncology.
June 1-5, 2007. Chicago, IL. Abstract #526
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A
comparison of estrogen receptor (ER) measurement by three methods in
node-negative, estrogen receptor (ER)-positive breast cancer:
Ligand binding (LB), immunohistochemistry (IHC), and quantitative RT-PCR.
Kim C, Tang G, Baehner FL, Watson D, Costantino JP, Paik S, Shak S, Wolmark N.
Presented at: 29th Annual San Antonio Breast Cancer Symposium. December 14-17,
2006. San Antonio, TX. Abstract #3116
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The
impact on the Recurrence Score due to patient variation in the quantitative
expression of individual genes or gene groups.
Watson D, Palmer G, Baker J, Shak S.
Presented at: 29th Annual San Antonio Breast Cancer Symposium. December 14-17,
2006. San Antonio, TX. Abstract #6039
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Subtypes
of breast cancer defined by standardized quantitative RT-PCR analysis of 10,618
tumors.
Shak S, Baehner FL, Palmer G, Ballard JT, Baker J, Watson D.
Presented at: 29th Annual San Antonio Breast Cancer Symposium. December 14-17,
2006. San Antonio, TX. Abstract #6118
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Relationship
between proliferation genes and expression of hormone and growth factor
receptors: quantitative RT-PCR in 10,618 breast cancers.
Shak S, Baehner FL, Palmer G, Ballard JT, Baker J, Watson D.
Presented at: 29th Annual San Antonio Breast Cancer Symposium. December 14-17,
2006. San Antonio, TX. Abstract #6111
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Quantitative
RT-PCR analysis of ER and PR by Oncotype DX indicates distinct and
different associations with prognosis and prediction of tamoxifen benefit.
Baehner FL, Habel LA, Quesenberry CP, Capra A, Tang G, Paik S, Wolmark N,
Watson D, Shak S.
Presented at: 29th Annual San Antonio Breast Cancer Symposium. December 14-17,
2006. San Antonio, TX. Abstract #45
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Predicting response to primary chemotherapy: gene expression profiling of paraffin-embedded core biopsy tissue.
L Mina, Soule SE, Badve S, Baehner FL, Baker J, Cronin M, Watson D, Liu ML,
Sledge Jr. GW, Shak S, Miller KD.
Breast Cancer Res Treat. 2007;103(2):197-208
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Measurement of gene expression using tissue microarray cores of paraffin embedded breast cancer tissue.
Baker J, Salter J, Liu ML, Hackett JR, Cronin M, Shak S, Dowsett M.
Presented at: 28th Annual San Antonio Breast Cancer Symposium. December 8-11,
2005. San Antonio, TX. Abstract #310
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Asssociation of individual genes with risk of relapse in operable breast cancer: Analysis of E2197.
Sparano JA, Goldstein L, Childs B, Yoshizawa C, Shak S, Baker J, Rowley S,
Davidson N, Badve S, Sledge Jr. GW, Gray R.
Presented at: The 2007 ASCO Breast Cancer Symposium. September 7-8, 2007. San
Francisco, California. Abstract #27
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Reproducibility
of quantitative gene expression analysis by a new RT-PCR assay using fixed
paraffin-embedded tissues: A molecular tomographic scanning study.
Cronin M, Watson D, Dutta D, Liu ML, Pho M, Baehner R, Esteban J, Baker J, Shak
S
Presented at: United States and Canadian Academy of Pathology Annual Meeting.
March 6 - 12, 2004. Vancouver, British Columbia. Abstract #1491
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