The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase

European Journal of Cancer

Volumn 47, Issue 18, 2011, Pages 2742-2749

  Rutgers, Emiel ^a   Piccart Gebhart, Martine J ^b   Bogaerts, Jan ^c   Delaloge, Suzette ^d   Veer, Laura Van't L ^a   Rubio, Isabel Teresa ^e   Viale, Giuseppe ^f,g   Thompson, Alastair M ^h   Passalacqua, Rodolfo ⁱ   Nitz, Ulrike ^j   Vindevoghel, Anita ^k   Pierga, Jean Yves ^l   Ravdin, Peter M ^m   Werutsky, Gustavo ^c   Cardoso, Fatima ^b  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b JULES BORDET INSTITUTE   (Belgium)

^c EORTC DATA CENTER   (Belgium)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^f EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^g UNIVERSITY OF MILAN   (Italy)

^h NINEWELLS HOSPITAL   (United Kingdom)

ⁱ CREMONA HOSPITAL   (Italy)

^j Niederrhein Breast Centre   (Germany)

^k Clinique & Maternite Sainte Elisabeth Namer   (Belgium)

^l INSTITUT CURIE   (France)

^m UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

more..

Author keywords

Breast cancer; Chemotherapy; Endocrine therapy; Gene expression signatures; Genomics; MammaPrint ; Pilot study

Indexed keywords

ANTHRACYCLINE; CAPECITABINE; DOCETAXEL; LETROZOLE; TAMOXIFEN;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RISK; CANCER SCREENING; CONFIDENCE INTERVAL; CONTROLLED STUDY; FEASIBILITY STUDY; FEMALE; GENOMICS; HORMONAL THERAPY; HUMAN; MAJOR CLINICAL STUDY; MICROARRAY ANALYSIS; PATIENT DECISION MAKING; PHASE 3 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; AGED; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; FEMALE; HUMANS; MIDDLE AGED; PATIENT COMPLIANCE; PILOT PROJECTS;

EID: 82255175550     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.09.016     Document Type: Article

References (30)

1. J. Ferlay, P. Autier, and M. Boniol Estimates of the cancer incidence and mortality in Europe in 2006 Ann Oncol 18 3 2007 581 592 (Pubitemid 46359643)
2. A. Jemal, R. Siegel, and E. Ward Cancer statistics, 2009 CA Cancer J Clin 59 4 2009 225 249
3. P.M. Ravdin, K.A. Cronin, and N. Howlader The decrease in breast-cancer incidence in 2003 in the United States N Engl J Med 356 16 2007 1670 1674 (Pubitemid 46631679)
4. K.A. Cronin, P.M. Ravdin, and B.K. Edwards Sustained lower rates of breast cancer in the United States Breast Cancer Res Treat 117 1 2009 223 224
5. D.A. Berry, K.A. Cronin, and S.K. Plevritis Effect of screening and adjuvant therapy on mortality from breast cancer N Engl J Med 353 17 2005 1784 1792 (Pubitemid 41549890)
6. R.T. Chlebowski, L.H. Kuller, and R.L. Prentice Breast cancer after use of estrogen plus progestin in postmenopausal women N Engl J Med 360 6 2009 573 587
7. Screening for breast cancer: U.S. preventive services task force recommendation statement. Ann Intern Med 2009;151(10):716-236.
8. Van 't Veer LJ, Esserman LJ., Linn S, et al. Evaluation of the effect of screening on the detection of good and poor prognosis breast cancers. In ASCO annual meeting proceedings (post-meeting edition). J Clin Oncol 2009; 27(15S) (May 20 Supplement):1525.
9. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005;365(9472):1687-1717.
10. L. Harris, H. Fritsche, and R. Mennel American society of clinical oncology 2007 update of recommendations for the use of tumor markers in breast cancer J Clin Oncol 25 33 2007 5287 5312 (Pubitemid 350232263)
11. P. Eifel, J.A. Axelson, and J. Costa National institutes of health consensus development conference statement: adjuvant therapy for breast cancer, November 1-3, 2000 J Natl Cancer Inst 93 13 2001 979 989
12. R.W. Carlson, D.C. Allred, and B.O. Anderson Breast cancer. Clinical practice guidelines in oncology J Natl Compr Canc Netw 7 2 2009 122 192
13. V. Kataja, and M. Castiglione Primary breast cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up Ann Oncol 20 Suppl. 4 2009 10 14
14. J.L. Haybittle, R.W. Blamey, and C.W. Elston A prognostic index in primary breast cancer Br J Cancer 45 3 1982 361 366 (Pubitemid 12122304)
15. A. Goldhirsch, W.C. Wood, and A.S. Coates Strategies for subtypes-dealing with the diversity of breast cancer: highlights of the St Gallen international expert consensus on the primary therapy of early breast cancer 2011 Ann Oncol 22 8 2011 1736 1747
16. C.M. Perou, T. Sorlie, and M.B. Eisen Molecular portraits of human breast tumours Nature 406 6797 2000 747 752
17. Oakman C, Bessi S, Zafarana E, Galardi F, Biganzoli L, Di LA. Recent advances in systemic therapy: new diagnostics and biological predictors of outcome in early breast cancer. Breast Cancer Res 2009;11(2):205.
18. van 't Veer LJ, Dai H, van de Vijver MJ, et al. Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002;415(6871):530-536. (Pubitemid 34130608)
19. S. Michiels, S. Koscielny, and C. Hill Prediction of cancer outcome with microarrays: a multiple random validation strategy Lancet 365 9458 2005 488 492 (Pubitemid 40215731)
20. S. Paik, S. Shak, and G. Tang A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer N Engl J Med 351 27 2004 2817 2826 (Pubitemid 40051905)
21. S. Mook, M.K. Schmidt, and G. Viale The 70-gene prognosis-signature predicts disease outcome in breast cancer patients with 1-3 positive lymph nodes in an independent validation study Breast Cancer Res Treat 116 2 2009 295 302
22. K.S. Albain, W.E. Barlow, and S. Shak Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial Lancet Oncol 11 1 2010 55 65
23. van de Vijver MJ, He YD, van't Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 2002;347(25):1999-2009. (Pubitemid 35461656)
24. M. Knauer, S. Mook, and E.J. Rutgers The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer Breast Cancer Res Treat 120 3 2010 655 661
25. M.E. Straver, A.M. Glas, and J. Hannemann The 70-gene signature as a response predictor for neoadjuvant chemotherapy in breast cancer Breast Cancer Res Treat 119 3 2010 551 558
26. M. Buyse, S. Loi, and L. van't Veer Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer J Natl Cancer Inst 98 17 2006 1183 1192 (Pubitemid 44390989)
27. J. Bogaerts, F. Cardoso, and M. Buyse Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial Nat Clin Pract Oncol 3 10 2006 540 551 (Pubitemid 44781724)
28. J.M. Bueno-de-Mesquita, W.H. van Harten, and V.P. Retel Use of 70-gene signature to predict prognosis of patients with node-negative breast cancer: a prospective community-based feasibility study (RASTER) Lancet Oncol 8 12 2007 1079 1087 (Pubitemid 350182954)
29. S. Mook, H. Bonnefoi, and G. Pruneri Daily clinical practice of fresh tumour tissue freezing and gene expression profiling; logistics pilot study preceding the MINDACT trial Eur J Cancer 45 7 2009 1201 1208
30. B. Freidlin, L.M. McShane, and E.L. Korn Randomized clinical trials with biomarkers: design issues J Natl Cancer Inst 102 3 2010 152 160