Clinical Validation

Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population
Toi M, Iwata H, Yamanaka T, et al.
Cancer. 2010; 116(13):3113-3118.

A Multigene Expression Assay to Predict Local Recurrence Risk for Ductal Carcinoma In Situ of the Breast
Solin L.J., Gray R, Baehner F.L., et al.
Journal of the National Cancer Institute. 2013; 105(10):701-710.

Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Breast Cancer Patients Treated with Anastrozole or Tamoxifen: A TransATAC Study
M Dowsett, J Cuzick, C Wale, J Forbes, EA Mallon, J Salter, E Quinn, A Dunbier, M Baum, A Buzdar, A Howell, R Bugarini, FL Baehner FL, Shak S.
J Clin Oncol. 2010; 28:11.


Validation of a 12-Gene Colon Cancer Recurrence Score (RS) in Patients (pts) with Stage II Colon Cancer (CC) from CALGB 9581
A. P. Venook, D. Niedzwiecki, M. Lopatin, M. Lee, P. N. Friedman, W. Frankel, K. Clark-Langone, C. Yoshizawa, C. Millward, S. Shak, R. M. Goldberg, N. N. Mahmoud, R. L. Schilsky, M. M. Bertagnolli, Cancer and Leukemia Group B; University of California, San Francisco, San Francisco, CA; Duke University, Durham, NC; Genomic Health, Redwood City, CA; Cancer and Leukemia Group B, Chicago, IL; The Ohio State University, Columbus, OH; University of North Carolina at Chapel Hill, Chapel Hill, NC; University of Pennsylvania, Philadelphia, PA; The University of Chicago, Chicago, IL; Brigham and Women's Hospital, Boston, MA
Abstract #3518

Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal, Node-Positive, Estrogen Receptor-Positive Breast Cancer
K Albain, W Barlo, S Shak, G Hortobagyi, R Livingston, I-T Yeh, P Ravdin,R Bugarini, FL Baehner, NE Davidson, GW Sledge, E Winer, C Hudis, JIngle, E Perez, K Pritchard, L Shepherd, J Gralow, C Yoshizawa, D Allred, C Osborne, D Hayes


Risk of distant recurrence using Oncotype DX in postmenopausal primary breast
Dowsett M, Cuzick J, Wales C, Forbes J, Mallon L, Salter J, Quinn E, Bugarini R,
Abstract # 53

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik
12(6):631-635.


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
LJ Goldstein, R Gray, B Childs, D Watson, S Rowley, S Shak, S Badve, NE Davidson, GW Sledge, JA Sparano
Abstract #526 : Poster Discussion


Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal, Node-Positive, ER-Positive Breast Cancer
K Albain, W Barlow, S Shak, G Hortobagyi, R Livingston, I Yeh, P Ravdin, C Yoshizawa, FL Baehner, N Davidson, G Sledge, E Winer, C Hudis, J Ingle, E Perez, K Pritchard, L Shepherd, C Allred, K Osborne, D Hayes
Abstract #10 : Oral Presentation

A Population-Based Study of Tumor Gene Expression and Risk of Breast Cancer Death Among Lymph Node-Negative Patients
LA Habel, S Shak, M Jacobs, A Capra, C Alexander, M Pho, J Baker, MG Walker, D Watson, J Hackett, N Blick, D Greenberg, L Fehrenbacher, B Langholz, CP Quesenberry
R25.

Gene Expression and Benefit of Chemotherapy in Women with Node-Negative, Estrogen Receptor-Positive Breast Cancer
S Paik, G Tang, S Shak, C Kim, J Baker, W Kim, M Cronin, FL Baehner, D Watson, J Bryant, JP Costantino, C Geyer Jr., DL Wickerham, N Wolmark
24(23):3726-3734.

A Step in the Right Direction
S Swain
J Clin Oncol. 2006; 24(23):3717-3718.


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
E Mamounas, G Tang, J Bryant, S Paik, S Shak, JP Costantino, D Watson, DL Wickerham, N Wolmark
Abstract #29 : Oral Presentation


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
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, D Watson, J Bryant, JP Costantino, N Wolmark
Abstract #510 : Oral Presentation


Gene Expression and Breast Cancer Mortality in Northern California Kaiser Permanente Patients: A Large Population-Based Case Control Study
LA Habel, CP Quesenberry, M Jacobs, D Greenberg, L Fehrenbacher, C Alexander, J Baker, D Watson, J Hackett, S Shak
Abstract #603 : Poster Session


Expression of the 21 Genes in the Recurrence Score Assay and Prediction of Clinical Benefit from Tamoxifen in NSABP Study B-14 and Chemotherapy in NSABP Study B-20
S Paik, S Shak, G Tang, C Kim, H Joo, J Baker, M Cronin, D Watson, J Bryant, JP Costantino, N Wolmark
Abstract #24 : Oral Presentation


Risk Classification of Breast Cancer Patients by the Recurrence Score Assay: Comparison to Guidelines Based on Patient Age, Tumor Size, and Tumor Grade
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, D Watson, J Bryant, N Wolmark
Abstract #104 : Poster Discussion

Individualized Care for Patients With Cancer - A Work In Progress
RC Bast, GN Hortobagyi
N Engl J Med. 2004; 351(27):2865-2867.

A Multigene Assay to Predict Recurrence of Tamoxifen Treated Node-Negative Breast Cancer
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, D Watson, T Park, W Hiller, ER Fisher, DL Wickerham, J Bryant, N Wolmark
2817-2826.


Multi-Gene RT-PCR Assay for Predicting Recurrence in Node-Negative Breast Cancer Patients - NSABP Studies B-20 and B-14
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, DWatson, T Park, W Hiller, ER Fisher, DL Wickerham, J Bryant, N Wolmark
Abstract #16 : Oral Presentation


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
L Goldstein, P Ravdin, R Gray, C Yoshizawa, B Childs, S Rowley, S Shak, S Badve, FL Baehner, N Davidson, GW Sledge, JA Sparano
Abstract #63 : Oral Presentation

The First Report Of The Association Between The Recurrence Score And The Risk Of Recurrence In A Japanese Population
M. Toi, H. Iwata, N. Masuda, S. Ohno, S. Namakura, Y.Yamanaka, T. Nakayama, M. Kashiwaba, S, Kamigaki, K. Aogi, T. Ueno, K. Kuroi.