Journal Article
. 2007 May;25(15).
doi: 10.1200/JCO.2006.10.3523.

Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system

Clifford A Hudis 1 William E Barlow  Joseph P Costantino  Robert J Gray  Kathleen I Pritchard  Judith-Anne W Chapman  Joseph A Sparano  Sally Hunsberger  Rebecca A Enos  Richard D Gelber  Jo Anne Zujewski  
  • PMID: 17513820
  •     248 citations


Purpose: Standardized definitions of breast cancer clinical trial end points must be adopted to permit the consistent interpretation and analysis of breast cancer clinical trials and to facilitate cross-trial comparisons and meta-analyses. Standardizing terms will allow for uniformity in data collection across studies, which will optimize clinical trial utility and efficiency. A given end point term (eg, overall survival) used in a breast cancer trial should always encompass the same set of events (eg, death attributable to breast cancer, death attributable to cause other than breast cancer, death from unknown cause), and, in turn, each event within that end point should be commonly defined across end points and studies.

Methods: A panel of experts in breast cancer clinical trials representing medical oncology, biostatistics, and correlative science convened to formulate standard definitions and address the confusion that nonstandard definitions of widely used end point terms for a breast cancer clinical trial can generate. We propose standard definitions for efficacy end points and events in early-stage adjuvant breast cancer clinical trials. In some cases, it is expected that the standard end points may not address a specific trial question, so that modified or customized end points would need to be prospectively defined and consistently used.

Conclusion: The use of the proposed common end point definitions will facilitate interpretation of trial outcomes. This approach may be adopted to develop standard outcome definitions for use in trials involving other cancer sites.

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Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival-Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL.
Nola M Hylton, Constantine A Gatsonis, +13 authors, ACRIN 6657 Trial Team and I-SPY 1 TRIAL Investigators.
Radiology, 2015 Dec 02; 279(1). PMID: 26624971    Free PMC article.
Highly Cited.
Postmastectomy radiotherapy benefit in Chinese breast cancer patients with T1-T2 tumor and 1-3 positive axillary lymph nodes by molecular subtypes: an analysis of 1369 cases.
Honghong Shen, Lin Zhao, +6 authors, Yun Niu.
Tumour Biol, 2015 Dec 04; 37(5). PMID: 26631044
Systemic Correlates of White Adipose Tissue Inflammation in Early-Stage Breast Cancer.
Neil M Iyengar, Xi Kathy Zhou, +9 authors, Andrew J Dannenberg.
Clin Cancer Res, 2015 Dec 30; 22(9). PMID: 26712688    Free PMC article.
Highly Cited.
Diagnostic and Prognostic Value of Circulating Tumor Cells in Head and Neck Squamous Cell Carcinoma: a systematic review and meta-analysis.
Xiang-Lei Wu, Qian Tu, +3 authors, Marcelo De Carvalho Bittencourt.
Sci Rep, 2016 Feb 03; 6. PMID: 26831813    Free PMC article.
Systematic Review.
Effect of young age, positive margins, and triple negative status on disease recurrence after breast conserving therapy.
Panuwat Lertsithichai, Bundit Sakulchairungreung, +5 authors, Youwanush Kongdan.
Gland Surg, 2016 Feb 09; 5(1). PMID: 26855904    Free PMC article.
Stratification of Prognosis of Triple-Negative Breast Cancer Patients Using Combinatorial Biomarkers.
Yong Yue, Kristine Astvatsaturyan, +3 authors, Shikha Bose.
PLoS One, 2016 Mar 02; 11(3). PMID: 26930401    Free PMC article.
Background Parenchymal Enhancement on Preoperative Magnetic Resonance Imaging: Association With Recurrence-Free Survival in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy.
Ji Soo Choi, Eun Sook Ko, +2 authors, Seok Jin Nam.
Medicine (Baltimore), 2016 Mar 06; 95(9). PMID: 26945421    Free PMC article.
Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer: final survival analysis of the ADEBAR study.
W Janni, N Harbeck, +9 authors, M Kiechle.
Br J Cancer, 2016 Apr 01; 114(8). PMID: 27031854    Free PMC article.
Prognostic Value of Circulating Tumor Cells Identified Before Surgical Resection in Nonmetastatic Breast Cancer Patients.
Carolyn S Hall, Mandar G Karhade, +4 authors, Anthony Lucci.
J Am Coll Surg, 2016 Apr 07; 223(1). PMID: 27049782    Free PMC article.
Prognostic and predictive value of Ki-67 in triple-negative breast cancer.
Wei Wang, Jiayi Wu, +9 authors, Li Zhu.
Oncotarget, 2016 May 05; 7(21). PMID: 27145269    Free PMC article.
Lymphovascular invasion is an independent predictor of survival in breast cancer after neoadjuvant chemotherapy.
Ying L Liu, Anurag Saraf, +4 authors, Eileen P Connolly.
Breast Cancer Res Treat, 2016 May 27; 157(3). PMID: 27225388    Free PMC article.
Clinical development of new drug-radiotherapy combinations.
Ricky A Sharma, Ruth Plummer, +37 authors, NCRI CTRad Academia-Pharma Joint Working Group.
Nat Rev Clin Oncol, 2016 Jun 02; 13(10). PMID: 27245279
Highly Cited.
RAB2A controls MT1-MMP endocytic and E-cadherin polarized Golgi trafficking to promote invasive breast cancer programs.
Hiroaki Kajiho, Yuko Kajiho, +12 authors, Giorgio Scita.
EMBO reports, 2016 Jun 04; 17(7). PMID: 27255086    Free PMC article.
Evaluation of the prognostic value of tumor-infiltrating lymphocytes in triple-negative breast cancers.
Tian Tian, Miao Ruan, Wentao Yang, Ruohong Shui.
Oncotarget, 2016 Jun 22; 7(28). PMID: 27323808    Free PMC article.
Challenges in translating endpoints from trials to observational cohort studies in oncology.
Anne Gulbech Ording, Deirdre Cronin-Fenton, +4 authors, Henrik Toft Sørensen.
Clin Epidemiol, 2016 Jun 30; 8. PMID: 27354827    Free PMC article.
Detection of circulating tumor cells using manually performed immunocytochemistry (MICC) does not correlate with outcome in patients with early breast cancer - Results of the German SUCCESS-A- trial.
Julia Jueckstock, Brigitte Rack, +16 authors, SUCCESS Study Group.
BMC Cancer, 2016 Jul 09; 16. PMID: 27387743    Free PMC article.
Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer.
Cristina Fernández-López, José Expósito-Hernández, +5 authors, José Cabeza-Barrera.
Cancer Med, 2016 Jul 28; 5(9). PMID: 27449070    Free PMC article.
Survival is associated with complete response on MRI after neoadjuvant chemotherapy in ER-positive HER2-negative breast cancer.
Claudette E Loo, Lisanne S Rigter, +5 authors, Kenneth G A Gilhuijs.
Breast Cancer Res, 2016 Aug 09; 18(1). PMID: 27495815    Free PMC article.
Association of Locoregional Control With High Body Mass Index in Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer.
Carmen Bergom, Tracy Kelly, +7 authors, Julia White.
Int J Radiat Oncol Biol Phys, 2016 Aug 12; 96(1). PMID: 27511848    Free PMC article.
Breast carcinoma with an Oncotype Dx recurrence score <18: Rate of distant metastases in a large series with clinical follow-up.
Hannah Y Wen, Melissa Krystel-Whittemore, +7 authors, Edi Brogi.
Cancer, 2016 Aug 16; 123(1). PMID: 27526056    Free PMC article.
Trends in endpoint selection in clinical trials of advanced breast cancer.
Seung Yeon Song, Heenam Seo, +2 authors, Eun Young Kim.
J Cancer Res Clin Oncol, 2016 Sep 03; 142(11). PMID: 27586374
Adjuvant Chemotherapy and Trastuzumab Is Safe and Effective in Older Women With Small, Node-Negative, HER2-Positive Early-Stage Breast Cancer.
Karen A Cadoo, Patrick G Morris, +3 authors, Heather L McArthur.
Clin Breast Cancer, 2016 Sep 14; 16(6). PMID: 27622751    Free PMC article.
Value of volume-based metabolic parameters for predicting survival in breast cancer patients treated with neoadjuvant chemotherapy.
Tae Hee Kim, Joon-Kee Yoon, +6 authors, Young-Sil An.
Medicine (Baltimore), 2016 Oct 16; 95(41). PMID: 27741099    Free PMC article.
Genetic Polymorphisms in the Long Noncoding RNA MIR2052HG Offer a Pharmacogenomic Basis for the Response of Breast Cancer Patients to Aromatase Inhibitor Therapy.
James N Ingle, Fang Xie, +15 authors, Liewei Wang.
Cancer Res, 2016 Oct 21; 76(23). PMID: 27758888    Free PMC article.
ADD-ASPIRIN: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.
Christopher Coyle, Fay H Cafferty, +11 authors, Add-Aspirin investigators.
Contemp Clin Trials, 2016 Oct 30; 51. PMID: 27777129    Free PMC article.
Association of Serum Level of Vitamin D at Diagnosis With Breast Cancer Survival: A Case-Cohort Analysis in the Pathways Study.
Song Yao, Marilyn L Kwan, +11 authors, Lawrence H Kushi.
JAMA Oncol, 2016 Nov 11; 3(3). PMID: 27832250    Free PMC article.
Cytoplasmic Cyclin E Predicts Recurrence in Patients with Breast Cancer.
Kelly K Hunt, Cansu Karakas, +13 authors, Khandan Keyomarsi.
Clin Cancer Res, 2016 Nov 25; 23(12). PMID: 27881578    Free PMC article.
Prognostic Value of MammaPrint® in Invasive Lobular Breast Cancer.
Inès J Beumer, Marion Persoon, +9 authors, Annuska M Glas.
Biomark Insights, 2016 Dec 17; 11. PMID: 27980389    Free PMC article.
Multimodality treatment for esophageal adenocarcinoma: multi-center propensity-score matched study.
S R Markar, B J Noordman, +12 authors, G B Hanna.
Ann Oncol, 2017 Jan 01; 28(3). PMID: 28039180    Free PMC article.
Location of Receipt of Initial Treatment and Outcomes in Long-Term Breast Cancer Survivors.
Arup K Sinha, Jenil R Patel, +5 authors, Carlos H Barcenas.
PLoS One, 2017 Jan 14; 12(1). PMID: 28085940    Free PMC article.
Cyclin E overexpression as a biomarker for combination treatment strategies in inflammatory breast cancer.
Angela Alexander, Cansu Karakas, +12 authors, Khandan Keyomarsi.
Oncotarget, 2017 Jan 21; 8(9). PMID: 28107181    Free PMC article.
Update on Trial Registration 11 Years after the ICMJE Policy Was Established.
Deborah A Zarin, Tony Tse, Rebecca J Williams, Thiyagu Rajakannan.
N Engl J Med, 2017 Jan 26; 376(4). PMID: 28121511    Free PMC article.
Highly Cited.
Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype.
W Fraser Symmans, Caimiao Wei, +17 authors, Gabriel N Hortobagyi.
J Clin Oncol, 2017 Jan 31; 35(10). PMID: 28135148    Free PMC article.
Highly Cited.
Polymorphisms of ESR1, UGT1A1, HCN1, MAP3K1 and CYP2B6 are associated with the prognosis of hormone receptor-positive early breast cancer.
Sung-Hsin Kuo, Shi-Yi Yang, +4 authors, Chiun-Sheng Huang.
Oncotarget, 2017 Feb 09; 8(13). PMID: 28178648    Free PMC article.
Association of osteopontin with specific prognostic factors and survival in adjuvant breast cancer trials of the Hellenic Cooperative Oncology Group.
Amanda Psyrri, Konstantine T Kalogeras, +21 authors, George Fountzilas.
J Transl Med, 2017 Feb 15; 15(1). PMID: 28193231    Free PMC article.
Outcomes in patients with early-stage breast cancer who underwent a 21-gene expression assay.
Carlos H Barcenas, Akshara Raghavendra, +10 authors, Debu Tripathy.
Cancer, 2017 Feb 16; 123(13). PMID: 28199747    Free PMC article.
11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial.
David Cameron, Martine J Piccart-Gebhart, +16 authors, Herceptin Adjuvant (HERA) Trial Study Team.
Lancet, 2017 Feb 22; 389(10075). PMID: 28215665    Free PMC article.
Highly Cited.
P53 and Ki-67 as prognostic markers in triple-negative breast cancer patients.
Yunbao Pan, Yufen Yuan, Guoshi Liu, Yongchang Wei.
PLoS One, 2017 Feb 25; 12(2). PMID: 28235003    Free PMC article.
The scaffold protein p140Cap limits ERBB2-mediated breast cancer progression interfering with Rac GTPase-controlled circuitries.
Silvia Grasso, Jennifer Chapelle, +28 authors, Paola Defilippi.
Nat Commun, 2017 Mar 17; 8. PMID: 28300085    Free PMC article.
Are there patients with T1 to T2, lymph node-negative breast cancer who are "high-risk" for locoregional disease recurrence?
Anita Mamtani, Sujata Patil, Michelle M Stempel, Monica Morrow.
Cancer, 2017 Mar 24; 123(14). PMID: 28334423    Free PMC article.
Evidence for Detection Bias by Medication Use in a Cohort Study of Breast Cancer Survivors.
Heidi S Wirtz, Gregory S Calip, +4 authors, Denise M Boudreau.
Am J Epidemiol, 2017 Mar 25; 185(8). PMID: 28338879    Free PMC article.
Differences in subtype distribution between screen-detected and symptomatic invasive breast cancer and their impact on survival.
N Kobayashi, M Hikichi, +4 authors, T Utsumi.
Clin Transl Oncol, 2017 Apr 15; 19(10). PMID: 28409323
Comparison of Breast Cancer Molecular Features and Survival by African and European Ancestry in The Cancer Genome Atlas.
Dezheng Huo, Hai Hu, +17 authors, Olufunmilayo I Olopade.
JAMA Oncol, 2017 May 05; 3(12). PMID: 28472234    Free PMC article.
Highly Cited.
Comparison of residual cancer burden, American Joint Committee on Cancer staging and pathologic complete response in breast cancer after neoadjuvant chemotherapy: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657).
Jeffrey I Campbell, Christina Yau, +12 authors, Yunn-Yi Chen.
Breast Cancer Res Treat, 2017 Jun 04; 165(1). PMID: 28577078    Free PMC article.
Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer.
Gunter von Minckwitz, Marion Procter, +16 authors, APHINITY Steering Committee and Investigators.
N Engl J Med, 2017 Jun 06; 377(2). PMID: 28581356    Free PMC article.
Highly Cited.
Evaluation of the Prognostic Value of RANK, OPG, and RANKL mRNA Expression in Early Breast Cancer Patients Treated with Anthracycline-Based Adjuvant Chemotherapy.
Eleni Timotheadou, Konstantine T Kalogeras, +16 authors, George Fountzilas.
Transl Oncol, 2017 Jul 01; 10(4). PMID: 28666187    Free PMC article.
PAM50 gene signatures and breast cancer prognosis with adjuvant anthracycline- and taxane-based chemotherapy: correlative analysis of C9741 (Alliance).
Minetta C Liu, Brandelyn N Pitcher, +20 authors, William T Barry.
NPJ Breast Cancer, 2016 Jan 01; 2. PMID: 28691057    Free PMC article.
Oncologic Outcomes After Treatment for MRI Occult Breast Cancer (pT0N+).
Damian P McCartan, Emily C Zabor, +2 authors, Mahmoud B El-Tamer.
Ann Surg Oncol, 2017 Jul 14; 24(11). PMID: 28702770    Free PMC article.
21-Gene recurrence score and locoregional recurrence in lymph node-negative, estrogen receptor-positive breast cancer.
Gulisa Turashvili, Joanne F Chou, +5 authors, Hannah Y Wen.
Breast Cancer Res Treat, 2017 Jul 14; 166(1). PMID: 28702894    Free PMC article.
Germline Mutation Status, Pathological Complete Response, and Disease-Free Survival in Triple-Negative Breast Cancer: Secondary Analysis of the GeparSixto Randomized Clinical Trial.
Eric Hahnen, Bianca Lederer, +25 authors, Rita K Schmutzler.
JAMA Oncol, 2017 Jul 18; 3(10). PMID: 28715532    Free PMC article.
Highly Cited.
Letter to the Editor: Bacillus Calmette-Guerin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease.
Roger Li, Richard Sylvester, Colin P Dinney, Ashish M Kamat.
Bladder Cancer, 2017 Aug 22; 3(3). PMID: 28824941    Free PMC article.
Impact of histopathology, tumor-infiltrating lymphocytes, and adjuvant chemotherapy on prognosis of triple-negative breast cancer.
Roberto A Leon-Ferre, Mei-Yin Polley, +15 authors, Matthew P Goetz.
Breast Cancer Res Treat, 2017 Sep 16; 167(1). PMID: 28913760    Free PMC article.
Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design.
Jennifer A Ligibel, William T Barry, +17 authors, Pamela J Goodwin.
NPJ Breast Cancer, 2017 Sep 28; 3. PMID: 28948213    Free PMC article.
Obesity and survival in the neoadjuvant breast cancer setting: role of tumor subtype in an ethnically diverse population.
Ying L Liu, Anurag Saraf, +4 authors, Kevin Kalinsky.
Breast Cancer Res Treat, 2017 Sep 28; 167(1). PMID: 28948418    Free PMC article.
Magnetic resonance metabolic profiling of estrogen receptor-positive breast cancer: correlation with currently used molecular markers.
Ji Soo Choi, Dahye Yoon, +5 authors, Min Jung Kim.
Oncotarget, 2017 Oct 04; 8(38). PMID: 28969000    Free PMC article.
Herceptin® (trastuzumab) in HER2-positive early breast cancer: protocol for a systematic review and cumulative network meta-analysis.
Florence R Wilson, Megan E Coombes, +5 authors, Chris Cameron.
Syst Rev, 2017 Oct 12; 6(1). PMID: 29017563    Free PMC article.
Proteomic profiling of breast cancer metabolism identifies SHMT2 and ASCT2 as prognostic factors.
Stephan Bernhardt, Michaela Bayerlová, +15 authors, Eva Johanna Kantelhardt.
Breast Cancer Res, 2017 Oct 13; 19(1). PMID: 29020998    Free PMC article.
Prognostic significance of clinicopathological factors in early breast cancer: 20 years of follow-up in a single-center analysis.
Valentina Cocciolone, Katia Cannita, +11 authors, Corrado Ficorella.
Oncotarget, 2017 Oct 27; 8(42). PMID: 29069766    Free PMC article.
Impact of an In Situ Component on Outcome After In-Breast Tumor Recurrence in Patients Treated with Breast-Conserving Therapy.
James Laird, Benjamin Lok, +8 authors, Lior Z Braunstein.
Ann Surg Oncol, 2017 Nov 03; 25(1). PMID: 29094250    Free PMC article.
Rs1008805 polymorphism of CYP19A1 gene is associated with the efficacy of hormone therapy in stage I-II and operable stage III breast cancer.
Xiying Shao, Lei Luo, +13 authors, Xiaojia Wang.
Oncol Lett, 2017 Nov 09; 14(5). PMID: 29113261    Free PMC article.
A metastasis biomarker (MetaSite Breast™ Score) is associated with distant recurrence in hormone receptor-positive, HER2-negative early-stage breast cancer.
Joseph A Sparano, Robert Gray, +13 authors, Joan Jones.
NPJ Breast Cancer, 2017 Nov 16; 3. PMID: 29138761    Free PMC article.
Comparison of primary endpoints between publications, registries, and protocols of phase III cancer clinical trials.
Fei Liang, Xinmei Guo, +3 authors, Xichun Hu.
Oncotarget, 2017 Dec 13; 8(57). PMID: 29228640    Free PMC article.
Long-term survival outcomes of triple-receptor negative breast cancer survivors who are disease free at 5 years and relationship with low hormone receptor positivity.
S M Reddy, C H Barcenas, +5 authors, V Valero.
Br J Cancer, 2017 Dec 14; 118(1). PMID: 29235566    Free PMC article.
Determinants of Weight Gain During Adjuvant Endocrine Therapy and Association of Such Weight Gain With Recurrence in Long-term Breast Cancer Survivors.
Akshara Raghavendra, Arup K Sinha, +3 authors, Carlos H Barcenas.
Clin Breast Cancer, 2017 Dec 15; 18(1). PMID: 29239836    Free PMC article.
Accelerated hepatocellular carcinoma recurrence rate after postoperative direct-acting antivirals treatment - preliminary report.
Karola Warzyszyńska, Maurycy Jonas, +2 authors, Piotr Małkowski.
Clin Exp Hepatol, 2017 Dec 20; 3(4). PMID: 29255807    Free PMC article.
Breast carcinoma with 21-gene recurrence score lower than 18: rate of locoregional recurrence in a large series with clinical follow-up.
Gulisa Turashvili, Edi Brogi, +4 authors, Hannah Y Wen.
BMC Cancer, 2018 Jan 07; 18(1). PMID: 29304773    Free PMC article.
Extended Adjuvant Aromatase Inhibitor Therapy in Post-Menopausal Women.
Stephen M Schleicher, Maura N Dickler.
Curr Breast Cancer Rep, 2018 Feb 06; 9(4). PMID: 29399271    Free PMC article.
Incidence and risk factors for relapses in HIV-associated non-Hodgkin lymphoma as observed in the German HIV-related lymphoma cohort study.
Philipp Schommers, Daniel Gillor, +17 authors, Christian Hoffmann.
Haematologica, 2018 Feb 14; 103(5). PMID: 29439188    Free PMC article.
Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial.
Irene L Wapnir, Karen N Price, +20 authors, Breast International Group.
J Clin Oncol, 2018 Feb 15; 36(11). PMID: 29443653    Free PMC article.
Concurrent use of capecitabine with radiation therapy and survival in breast cancer (BC) after neoadjuvant chemotherapy.
Y L Liu, C Chin, +4 authors, E P Connolly.
Clin Transl Oncol, 2018 Mar 30; 20(10). PMID: 29594944
An Integrated TCGA Pan-Cancer Clinical Data Resource to Drive High-Quality Survival Outcome Analytics.
Jianfang Liu, Tara Lichtenberg, +13 authors, Hai Hu.
Cell, 2018 Apr 07; 173(2). PMID: 29625055    Free PMC article.
Highly Cited.
Evaluation of waiting times for breast cancer diagnosis and surgical treatment.
J M Baena-Cañada, L Rodríguez-Pérez, +7 authors, E Benítez-Rodríguez.
Clin Transl Oncol, 2018 Apr 11; 20(10). PMID: 29633184
Contralateral parenchymal enhancement on dynamic contrast-enhanced MRI reproduces as a biomarker of survival in ER-positive/HER2-negative breast cancer patients.
Bas H M van der Velden, Elizabeth J Sutton, +3 authors, Kenneth G A Gilhuijs.
Eur Radiol, 2018 May 08; 28(11). PMID: 29736850    Free PMC article.
Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2018 Jun 05; 379(2). PMID: 29860917    Free PMC article.
Highly Cited.
Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): An Abridged Explanation and Elaboration.
Willi Sauerbrei, Sheila E Taube, +2 authors, Douglas G Altman.
J Natl Cancer Inst, 2018 Jun 07; 110(8). PMID: 29873743    Free PMC article.
Highly Cited. Review.
Impact of pre-diagnostic triglycerides and HDL-cholesterol on breast cancer recurrence and survival by breast cancer subtypes.
Trygve Lofterød, Elin S Mortensen, +11 authors, Inger Thune.
BMC Cancer, 2018 Jun 16; 18(1). PMID: 29902993    Free PMC article.
Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103).
Kathy D Miller, Anne O'Neill, +12 authors, George W Sledge.
J Clin Oncol, 2018 Jul 25; 36(25). PMID: 30040523    Free PMC article.
Pathological Response and Survival in Triple-Negative Breast Cancer Following Neoadjuvant Carboplatin plus Docetaxel.
Priyanka Sharma, Sara López-Tarruella, +30 authors, Miguel Martín.
Clin Cancer Res, 2018 Aug 01; 24(23). PMID: 30061361    Free PMC article.
Systematic review of the impact of breast-conserving surgery on cancer outcomes of multiple ipsilateral breast cancers.
Z E Winters, J Horsnell, +13 authors, A M Brunt.
BJS Open, 2018 Aug 07; 2(4). PMID: 30079385    Free PMC article.
Survival Study of Triple-Negative and Non-Triple-Negative Breast Cancer in a Brazilian Cohort.
Homero Gonçalves, Maximiliano Ribeiro Guerra, +3 authors, Maria Teresa Bustamante Teixeira.
Clin Med Insights Oncol, 2018 Aug 08; 12. PMID: 30083066    Free PMC article.
Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial.
Ziyu Li, Fei Shan, +12 authors, Jiafu Ji.
BMJ Open, 2018 Aug 14; 8(8). PMID: 30099396    Free PMC article.
Co-expressed genes enhance precision of receptor status identification in breast cancer patients.
Michael Kenn, Dan Cacsire Castillo-Tong, +3 authors, Wolfgang Schreiner.
Breast Cancer Res Treat, 2018 Aug 18; 172(2). PMID: 30117066    Free PMC article.
Differential impact of circulating tumor cells on disease recurrence and survivals in patients with head and neck squamous cell carcinomas: An updated meta-analysis.
Jae-Keun Cho, Gil Joon Lee, +5 authors, Han-Sin Jeong.
PLoS One, 2018 Sep 08; 13(9). PMID: 30192876    Free PMC article.
Evaluation of the prognostic value of CD3, CD8, and FOXP3 mRNA expression in early-stage breast cancer patients treated with anthracycline-based adjuvant chemotherapy.
Marinos Tsiatas, Konstantine T Kalogeras, +17 authors, George Fountzilas.
Cancer Med, 2018 Sep 22; 7(10). PMID: 30240146    Free PMC article.
High Cytoplasmic CXCR4 Expression Predicts Prolonged Survival in Triple-Negative Breast Cancer Patients Treated with Adjuvant Chemotherapy.
Bobae Shim, Min-Sun Jin, +2 authors, Han Suk Ryu.
J Pathol Transl Med, 2018 Oct 03; 52(6). PMID: 30269472    Free PMC article.
Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.
Andrea DeCensi, Matteo Puntoni, +19 authors, Bernardo Bonanni.
J Clin Oncol, 2019 Apr 12; 37(19). PMID: 30973790    Free PMC article.
Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study.
Sara A Hurvitz, Miguel Martin, +18 authors, Dennis Slamon.
J Clin Oncol, 2019 Jun 04; 37(25). PMID: 31157583    Free PMC article.
Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.
Hyman B Muss, Mei-Yin C Polley, +25 authors, Lisa Carey.
J Clin Oncol, 2019 Jul 25; 37(26). PMID: 31339827    Free PMC article.
Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial.
Joseph A Sparano, Robert J Gray, +26 authors, George W Sledge.
JAMA Oncol, 2019 Oct 01; 6(3). PMID: 31566680    Free PMC article.
Whole-genome sequencing of triple-negative breast cancers in a population-based clinical study.
Johan Staaf, Dominik Glodzik, +18 authors, Serena Nik-Zainal.
Nat Med, 2019 Oct 02; 25(10). PMID: 31570822    Free PMC article.
Highly Cited.
The trans-DATA study: aims and design of a translational breast cancer prognostic marker identification study.
Tim C de Ruijter, Kim M Smits, +7 authors, Vivianne C G Tjan-Heijnen.
Diagn Progn Res, 2019 Oct 24; 3. PMID: 31641693    Free PMC article.
Pre- to postdiagnosis leisure-time physical activity and prognosis in postmenopausal breast cancer survivors.
Audrey Y Jung, Sabine Behrens, +6 authors, Jenny Chang-Claude.
Breast Cancer Res, 2019 Nov 07; 21(1). PMID: 31694687    Free PMC article.
Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial.
Patrice Forget, Gauthier Bouche, +13 authors, Martine Berliere.
PLoS One, 2019 Dec 05; 14(12). PMID: 31800611    Free PMC article.
Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol.
Lun Li, Benlong Yang, +17 authors, Jiong Wu.
BMJ Open, 2019 Dec 18; 9(12). PMID: 31843846    Free PMC article.
Comprehensive characterization of the rRNA metabolism-related genes in human cancer.
Kaisa Cui, Cheng Liu, +2 authors, Youjun Li.
Oncogene, 2019 Sep 25; 39(4). PMID: 31548613
Prognostic DNA methylation markers for hormone receptor breast cancer: a systematic review.
Tim C de Ruijter, Frank van der Heide, +3 authors, Vivianne C G Heijnen.
Breast Cancer Res, 2020 Feb 02; 22(1). PMID: 32005275    Free PMC article.
Systematic Review.
DNA methylation markers predict recurrence-free interval in triple-negative breast cancer.
Mary Jo Fackler, Soonweng Cho, +12 authors, Christopher B Umbricht.
NPJ Breast Cancer, 2020 Feb 07; 6. PMID: 32025567    Free PMC article.
Folate receptor alpha expression associates with improved disease-free survival in triple negative breast cancer patients.
Nadine Norton, Bahaaeldin Youssef, +18 authors, Keith L Knutson.
NPJ Breast Cancer, 2020 Feb 13; 6. PMID: 32047850    Free PMC article.
Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2019 Jun 04; 380(25). PMID: 31157962    Free PMC article.
Highly Cited.
6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial.
Helena M Earl, Louise Hiller, +30 authors, PERSEPHONE Steering Committee and Trial Investigators.
Lancet, 2019 Jun 11; 393(10191). PMID: 31178152    Free PMC article.
Highly Cited.
Prediction of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer via Early Changes in Tumor Heterogeneity Captured by DCE-MRI Registration.
Nariman Jahani, Eric Cohen, +6 authors, Despina Kontos.
Sci Rep, 2019 Aug 23; 9(1). PMID: 31431633    Free PMC article.
Association of caspase 8 polymorphisms -652 6N InsDel and Asp302His with progression-free survival and tumor infiltrating lymphocytes in early breast cancer.
Jan Dominik Kuhlmann, Hagen Sjard Bachmann, +7 authors, Eva Johanna Kantelhardt.
Sci Rep, 2019 Aug 31; 9(1). PMID: 31467295    Free PMC article.
Simulation Modeling of Cancer Clinical Trials: Application to Omitting Radiotherapy in Low-risk Breast Cancer.
Jinani Jayasekera, Yisheng Li, +21 authors, CISNET-BOLD Collaborative Group.
J Natl Cancer Inst, 2018 May 03; 110(12). PMID: 29718314    Free PMC article.
Automated volumetric radiomic analysis of breast cancer vascularization improves survival prediction in primary breast cancer.
Matthias Dietzel, Rüdiger Schulz-Wendtland, +7 authors, Pascal A T Baltzer.
Sci Rep, 2020 Mar 01; 10(1). PMID: 32111898    Free PMC article.
Effects of Radiotherapy in Early-Stage, Low-Recurrence Risk, Hormone-Sensitive Breast Cancer.
Jinani Jayasekera, Clyde B Schechter, +17 authors, CISNET-BOLD Collaborative Group.
J Natl Cancer Inst, 2018 Sep 22; 110(12). PMID: 30239794    Free PMC article.
Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial.
Thomas Ruhstaller, Anita Giobbie-Hurder, +27 authors, members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group.
J Clin Oncol, 2018 Nov 27; 37(2). PMID: 30475668    Free PMC article.
Efficacy of anastrozole after tamoxifen in early breast cancer patients with chemotherapy-induced ovarian function failure.
Irene E G van Hellemond, Ingeborg J H Vriens, +15 authors, Dutch Breast Cancer Research Group (BOOG).
Int J Cancer, 2018 Dec 28; 145(1). PMID: 30588619    Free PMC article.
Association of tumor-infiltrating lymphocytes with distant disease-free survival in the ShortHER randomized adjuvant trial for patients with early HER2+ breast cancer.
M V Dieci, P Conte, +19 authors, V Guarneri.
Ann Oncol, 2019 Jan 19; 30(3). PMID: 30657852    Free PMC article.
Radiologic complete response (rCR) in contrast-enhanced magnetic resonance imaging (CE-MRI) after neoadjuvant chemotherapy for early breast cancer predicts recurrence-free survival but not pathologic complete response (pCR).
Simon Peter Gampenrieder, Andreas Peer, +14 authors, Richard Greil.
Breast Cancer Res, 2019 Feb 02; 21(1). PMID: 30704493    Free PMC article.
Metastatic breast cancer incidence, site and survival in Australia, 2001-2016: a population-based health record linkage study protocol.
Sarah J Lord, Belinda E Kiely, +5 authors, Nehmat Houssami.
BMJ Open, 2019 Feb 03; 9(2). PMID: 30709862    Free PMC article.
Sentinel lymph node biopsy in microinvasive ductal carcinoma in situ.
F Magnoni, G Massari, +6 authors, V S Sacchini.
Br J Surg, 2019 Feb 23; 106(4). PMID: 30791092    Free PMC article.
Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98.
Kevin H Kensler, Meredith M Regan, +10 authors, Rulla M Tamimi.
Breast Cancer Res, 2019 Feb 24; 21(1). PMID: 30795773    Free PMC article.
Molecular apocrine tumours in EORTC 10994/BIG 1-00 phase III study: pathological response after neoadjuvant chemotherapy and clinical outcomes.
Hervé Bonnefoi, Gaetan MacGrogan, +16 authors, EORTC 10994/BIG 1-00 study investigators.
Br J Cancer, 2019 Mar 23; 120(9). PMID: 30899086    Free PMC article.
Risk of second breast cancer events with chronic opioid use in breast cancer survivors.
Denise M Boudreau, Lu Chen, +2 authors, Jessica Chubak.
Pharmacoepidemiol Drug Saf, 2019 Apr 05; 28(5). PMID: 30945381    Free PMC article.
Breast and cervical cancer patients' experience in Addis Ababa city, Ethiopia: a follow-up study protocol.
Alem Gebremariam, Adamu Addissie, +5 authors, Ahmedin Jemal.
BMJ Open, 2019 Apr 11; 9(4). PMID: 30967409    Free PMC article.
A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses.
Wanling Xie, Susan Halabi, +6 authors, Meredith M Regan.
JNCI Cancer Spectr, 2019 Jul 31; 3(1). PMID: 31360890    Free PMC article.
High-Dose Chemotherapy With Hematopoietic Stem Cell Transplant in Patients With High-Risk Breast Cancer and 4 or More Involved Axillary Lymph Nodes: 20-Year Follow-up of a Phase 3 Randomized Clinical Trial.
Tessa G Steenbruggen, Lars C Steggink, +18 authors, Jourik A Gietema.
JAMA Oncol, 2020 Jan 31; 6(4). PMID: 31999296    Free PMC article.
IGF-1R pathway activation as putative biomarker for linsitinib therapy to revert tamoxifen resistance in ER-positive breast cancer.
Dinja T Kruger, Xanthippi Alexi, +7 authors, Sabine C Linn.
Int J Cancer, 2019 Sep 07; 146(8). PMID: 31490549    Free PMC article.
Prognosis of PD-L1 in human breast cancer: protocol for a systematic review and meta-analysis.
Isnard Elman Litvin, Machline Paim Paganella, Eliana Marcia Wendland, Adriana Vial Roehe.
Syst Rev, 2020 Mar 29; 9(1). PMID: 32216835    Free PMC article.
Use of letrozole after aromatase inhibitor-based therapy in postmenopausal breast cancer (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled, phase 3 trial.
Eleftherios P Mamounas, Hanna Bandos, +17 authors, Norman Wolmark.
Lancet Oncol, 2018 Dec 05; 20(1). PMID: 30509771    Free PMC article.
Clinical features and survival of pregnancy-associated breast cancer: a retrospective study of 203 cases in China.
Bo-Yue Han, Xiao-Guang Li, +2 authors, Hong Ling.
BMC Cancer, 2020 Apr 16; 20(1). PMID: 32293328    Free PMC article.
Ki-67 index, progesterone receptor expression, histologic grade and tumor size in predicting breast cancer recurrence risk: A consecutive cohort study.
Yanna Zhang, Yidong Zhou, +2 authors, Qiang Sun.
Cancer Commun (Lond), 2020 Apr 16; 40(4). PMID: 32291973    Free PMC article.
Preserving fertility in young women undergoing chemotherapy for early breast cancer; the Maastricht experience.
Ingeborg J H Vriens, Elena M Ter Welle-Butalid, +16 authors, Vivianne C G Tjan-Heijnen.
Breast Cancer Res Treat, 2020 Apr 03; 181(1). PMID: 32236826    Free PMC article.
Simulation Modeling to Extend Clinical Trials of Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Early Breast Cancer.
Jinani Jayasekera, Joseph A Sparano, +5 authors, Jeanne Mandelblatt.
JNCI Cancer Spectr, 2020 Apr 28; 3(4). PMID: 32337487    Free PMC article.
Physical Activity and Mortality in Cancer Survivors: A Systematic Review and Meta-Analysis.
Christine M Friedenreich, Chelsea R Stone, Winson Y Cheung, Sandra C Hayes.
JNCI Cancer Spectr, 2020 Apr 28; 4(1). PMID: 32337494    Free PMC article.
A self-sustaining endocytic-based loop promotes breast cancer plasticity leading to aggressiveness and pro-metastatic behavior.
Irene Schiano Lomoriello, Giovanni Giangreco, +19 authors, Pier Paolo Di Fiore.
Nat Commun, 2020 Jun 17; 11(1). PMID: 32541686    Free PMC article.
National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.
Andrew D Seidman, Louise Bordeleau, +14 authors, Larissa A Korde.
J Clin Oncol, 2018 Sep 14; 36(32). PMID: 30212295    Free PMC article.
Borderline Estrogen Receptor-Positive Breast Cancers in Black and White Women.
Halei C Benefield, Emma H Allott, +6 authors, Melissa A Troester.
J Natl Cancer Inst, 2019 Nov 20; 112(7). PMID: 31742342    Free PMC article.
Monosomy 17 in potentially curable HER2-amplified breast cancer: prognostic and predictive impact.
David B Page, Hannah Wen, +7 authors, Heather L McArthur.
Breast Cancer Res Treat, 2017 Oct 08; 167(2). PMID: 28986743    Free PMC article.
Assessment of Long-term Distant Recurrence-Free Survival Associated With Tamoxifen Therapy in Postmenopausal Patients With Luminal A or Luminal B Breast Cancer.
Nancy Y Yu, Adina Iftimi, +10 authors, Linda S Lindström.
JAMA Oncol, 2019 Aug 09;. PMID: 31393518    Free PMC article.
Comprehensive molecular comparison of BRCA1 hypermethylated and BRCA1 mutated triple negative breast cancers.
Dominik Glodzik, Ana Bosch, +20 authors, Johan Staaf.
Nat Commun, 2020 Jul 29; 11(1). PMID: 32719340    Free PMC article.
Deep sequencing across germline genome-wide association study signals relating to breast cancer events in women receiving aromatase inhibitors for adjuvant therapy of early breast cancer.
James N Ingle, Krishna R Kalari, +14 authors, Liewei Wang.
Pharmacogenet Genomics, 2019 Jun 19; 29(8). PMID: 31211741    Free PMC article.
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies.
Shani Paluch-Shimon, Nathan I Cherny, +4 authors, Fatima Cardoso.
ESMO Open, 2020 Sep 08; 5(5). PMID: 32893189    Free PMC article.
Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT.
Helena Earl, Louise Hiller, +24 authors, Janet A Dunn.
Health Technol Assess, 2020 Sep 04; 24(40). PMID: 32880572    Free PMC article.
Platycodon grandiflorum Protects Against Anthracycline-Induced Cardiotoxicity in Early Breast Cancer Patients.
Wei Hao, Youyang Shi, +5 authors, Sheng Liu.
Integr Cancer Ther, 2020 Jul 31; 19. PMID: 32729334    Free PMC article.
Associations Between Circulating Insulin-Like Growth Factor 1 and Mortality in Women With Invasive Breast Cancer.
Yifei Zhu, Tiange Wang, +7 authors, Kunwei Shen.
Front Oncol, 2020 Sep 26; 10. PMID: 32974138    Free PMC article.
Benefits and risks of adjuvant treatment with zoledronic acid in stage II/III breast cancer. 10 years follow-up of the AZURE randomized clinical trial (BIG 01/04).
R E Coleman, M Collinson, +20 authors, D Cameron.
J Bone Oncol, 2018 Dec 29; 13. PMID: 30591866    Free PMC article.
Clinical validation of Ki67 by quantitative reverse transcription-polymerase chain reaction (RT-PCR) in HR+/HER2- early breast cancer.
Weiqi Gao, Jiayi Wu, +4 authors, Ou Huang.
J Cancer, 2019 Mar 12; 10(5). PMID: 30854118    Free PMC article.
Estrogen receptor variants in ER-positive basal-type breast cancers responding to therapy like ER-negative breast cancers.
Floris H Groenendijk, Tina Treece, +6 authors, Pat Whitworth.
NPJ Breast Cancer, 2019 Apr 25; 5. PMID: 31016233    Free PMC article.
Cytoplasmic HAX1 Is an Independent Risk Factor for Breast Cancer Metastasis.
Alicja Trebinska-Stryjewska, Lukasz Szafron, +7 authors, Ewa A Grzybowska.
J Oncol, 2019 May 17; 2019. PMID: 31093284    Free PMC article.
Clinical Relevance of Collagen Protein Degradation Markers C3M and C4M in the Serum of Breast Cancer Patients Treated with Neoadjuvant Therapy in the GeparQuinto Trial.
Malgorzata Banys-Paluchowski, Sibylle Loibl, +12 authors, Volkmar Müller.
Cancers (Basel), 2019 Aug 25; 11(8). PMID: 31443252    Free PMC article.
Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial.
Jayant S Vaidya, Max Bulsara, +36 authors, Jeffrey S Tobias.
BMJ, 2020 Aug 21; 370. PMID: 32816842    Free PMC article.
Prognostic impact of serum levels of EGFR and EGFR ligands in early-stage breast cancer.
Ina Mathilde Kjær, Dorte Aalund Olsen, +4 authors, Jonna Skov Madsen.
Sci Rep, 2020 Oct 08; 10(1). PMID: 33024132    Free PMC article.
A Novel Prognostic Scoring System Integrating Gene Expressions and Clinicopathological Characteristics to Predict Very Early Relapse in Node-Negative Estrogen Receptor-Positive/HER2-Negative Breast Cancer.
Caijin Lin, Jiayi Wu, +8 authors, Li Zhu.
Front Oncol, 2020 Oct 13; 10. PMID: 33042787    Free PMC article.
Hormonal Receptor Status Determines Prognostic Significance of FGFR2 in Invasive Breast Carcinoma.
Marcin Braun, Dominika Piasecka, +8 authors, Hanna M Romanska.
Cancers (Basel), 2020 Sep 26; 12(9). PMID: 32971804    Free PMC article.
Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.
Amelie de Gregorio, Lothar Häberle, +22 authors, Wolfgang Janni.
Breast Cancer Res, 2020 Oct 25; 22(1). PMID: 33097092    Free PMC article.
Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.
Sara M Tolaney, Hao Guo, +23 authors, Eric P Winer.
J Clin Oncol, 2019 Apr 03; 37(22). PMID: 30939096    Free PMC article.
Highly Cited.
A Five-Gene-Pair-Based Prognostic Signature for Predicting the Relapse Risk of Early Stage ER+ Breast Cancer.
Na Li, Hao Cai, +7 authors, Zheng Guo.
Front Genet, 2020 Nov 17; 11. PMID: 33193655    Free PMC article.
PD-1 protein and gene expression as prognostic factors in early breast cancer.
Alexios Matikas, Ioannis Zerdes, +7 authors, Theodoros Foukakis.
ESMO Open, 2020 Nov 12; 5(6). PMID: 33172959    Free PMC article.
Statistical Considerations for Trials in Adjuvant Treatment of Colorectal Cancer.
Everardo Delforge Saad, Marc Buyse.
Cancers (Basel), 2020 Nov 25; 12(11). PMID: 33228149    Free PMC article.