WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: Study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Hofmann, Daniel ^a   Nitz, Ulrike ^a,b   Gluz, Oleg ^a,b   Kates, Ronald E ^a   Schinkoethe, Timo ^c   Staib, Peter ^d   Harbeck, Nadia ^a,e  

^a West German Study Group   (Germany)

^b Bethesda Hospital   (Germany)

^c Institute for Innovation and Medicine   (Germany)

^d St Antonius Hospital   (Germany)

^e UNIVERSITY OF MUNICH   (Germany)

Author keywords

ADAPT; Biomarker; Early breast cancer; Investigator initiated trial

Indexed keywords

ANASTROZOLE; CARBOPLATIN; CYCLOPHOSPHAMIDE; EPIRUBICIN; EXEMESTANE; GEMCITABINE; LETROZOLE; PACLITAXEL; PERTUZUMAB; TAMOXIFEN; TRASTUZUMAB; TRASTUZUMAB EMTANSINE;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DISEASE MARKER; DYNAMICS; EARLY CANCER; FEMALE; FOLLOW UP; GERMANY; HORMONAL THERAPY; HUMAN; LOADING DRUG DOSE; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PERSONALIZED MEDICINE; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PREDICTION; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; TREATMENT RESPONSE; TUMOR VOLUME;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOPSY; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLINICAL PROTOCOLS; DECISION SUPPORT TECHNIQUES; EARLY DETECTION OF CANCER; FEMALE; GERMANY; HUMANS; INDIVIDUALIZED MEDICINE; KI-67 ANTIGEN; NEOADJUVANT THERAPY; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; RECEPTOR, ERBB-2; RESEARCH DESIGN; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; TRIPLE NEGATIVE BREAST NEOPLASMS; TUMOR MARKERS, BIOLOGICAL;

EID: 84883463405     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-261     Document Type: Article

References (28)

1. Al-Allak A, Lewis PD, Bertelli G. Decision-making tools to assist prognosis and treatment choices in early breast cancer: a review. Expert Rev Anticancer Ther 2012, 12:1033-1043. 10.1586/era.12.83, 23030223.
2. Kreipe HH, Ahrens P, Christgen M, Lehmann U, Länger F. Beyond staging, typing and grading. New challenges in breast cancer pathology. Pathologe 2010, 31(1):54-59. 10.1007/s00292-009-1244-y, 19949797.
3. Goncalves R, Bose R. Using multigene tests to select treatment for early-stage breast cancer. J Natl Compr Canc Netw 2013, 11(2):174-182.
4. Harbeck N, Schmitt M, Meisner C, Friedel C, Untch M, Schmidt M, Sweep CG, Lisboa BW, Lux MP, Beck T, Hasmüller S, Kiechle M, Jänicke F, Thomssen C. Ten-year analysis of the prospective multicenter Chemo-N0 trial validates American Society of Clinical Oncology (ASCO)-recommended biomarkers uPA and PAI-1 for therapy decision making in node-negative breast cancer patients. Eur J Cancer 2013, 49(8):1825-1835. 10.1016/j.ejca.2013.01.007, 23490655.
5. Zujewski JA, Kamin L. Trial assessing individualized options for treatment for breast cancer: the TAILORx trial. Future Oncol 2008, 4(5):603-610. 10.2217/14796694.4.5.603, 18922117.
6. Rutgers E, Piccart-Gebhart MJ, Bogaerts J, Delaloge S, Veer LV, Rubio IT, Viale G, Thompson AM, Passalacqua R, Nitz U, Vindevoghel A, Pierga JY, Ravdin PM, Werutsky G, Cardoso F. The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase. European J Cancer 2011, 47(18):2742-2749.
7. Kantelhardt EJ, Vetter M, Schmidt M, Veyret C, Augustin D, Hanf V, Meisner C, Paepke D, Schmitt M, Sweep F, von Minckwitz G, Martin PM, Jaenicke F, Thomssen C, Harbeck N. Prospective evaluation of prognostic factors uPA/PAI-1 in node-negative breast cancer: Phase III NNBC3-Europe trial (AGO, GBG, EORTC-PBG) comparing 6 × FEC versus 3 × FEC/3 × Docetaxel. BMC Cancer 2011, 11(1):140. 10.1186/1471-2407-11-140, 3089797, 21496284.
8. Harbeck N, Salem M, Nitz U, Gluz O, Liedtke C. Personalized treatment of early-stage breast cancer: present concepts and future directions. Cancer Treat Rev 2010, 36:584. 10.1016/j.ctrv.2010.04.007, 20554119.
9. Esserman LJ, Berry DA, Cheang MC, Yau C, Perou CM, Carey L, DeMichele A, Gray JW, Conway-Dorsey K, Lenburg ME, Buxton MB, Davis SE, van't Veer LJ, Hudis C, Chin K, Wolf D, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Livasy C, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen Y, Giri D, Au A, Hylton N. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 2012, 132(3):1049-1062. 10.1007/s10549-011-1895-2, 3332388, 22198468.
10. Bae YK, Gong G, Kang J, Lee A, Cho EY, Lee JS, Suh KS, Lee DW, Jung WH. The breast pathology study group of Korean Society of Pathologists, HER2 status by standardized immunohistochemistry and silver-enhanced in situ hybridization in Korean breast cancer. J Breast Cancer 2012, 15(4):381-387. 10.4048/jbc.2012.15.4.381, 3542844, 23346165.
11. Choritz H, Büsche G, Kreipe H. Study Group HER2 Monitor. Quality assessment of HER2 testing by monitoring of positivity rates. Virchows Arch 2011, 459(3):283-289. 10.1007/s00428-011-1132-8, 3162627, 21809092.
12. Von Minckwitz G, Kaufmann M, Kuemmel S, Fasching PA, Eiermann W, Blohmer JU, Costa SD, Hilfrich J, Jackisch C, Gerber B, Du Bois A, Huober JB, Hanusch CA, Konecny GE, Fett W, Stickeler E, Harbeck N, Mehta K, Loibl S, Untch M. Correlation of various pathologic complete response (pCR) definitions with long-term outcome and the prognostic value of pCR in various breast cancer subtypes: Results from the German neoadjuvant meta-analysis. J Clin Oncol 2011, 29(Suppl):abstr. 1028.
13. Spanheimer PM, Carr JC, Thomas A, Sugg SL, Scott-Conner CE, Liao J, Weigel RJ. The response to neoadjuvant chemotherapy predicts clinical outcome and increases breast conservation in advanced breast cancer. Am J Surg 2013, 206(1):2-7. 10.1016/j.amjsurg.2012.10.025, 23375759.
14. Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol 2010, 28:1829-1834. 10.1200/JCO.2009.24.4798, 20212256.
15. Joerger M, Thürlimann B. Chemotherapy regimens in early breast cancer: major controversies and future outlook. Expert Rev Anticancer Ther 2013, 13(2):165-178. 10.1586/era.12.172, 23406558.
16. Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, A'Hern R, Salter J, Detre S, Hills M, Walsh G. Prognostic value of Ki67 expression after short-term presurgical endocrine therapy for primary breast cancer. J Natl Cancer Inst 2007, 99:167-170. 10.1093/jnci/djk020, 17228000.
17. Luporsi E, André F, Spyratos F, Martin PM, Jacquemier J, Penault-Llorca F, Tubiana-Mathieu N, Sigal-Zafrani B, Arnould L, Gompel A, Egele C, Poulet B, Clough KB, Crouet H, Fourquet A, Lefranc JP, Mathelin C, Rouyer N, Serin D, Spielmann M, Haugh M, Chenard MP, Brain E, de Cremoux P, Bellocq JP. Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review. Breast Cancer Res Treat 2012, 132(3):895-915. 10.1007/s10549-011-1837-z, 3332349, 22048814.
18. Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat 2013, 138(1):99-108. 10.1007/s10549-013-2444-y, 3585916, 23420271.
19. World Medical Association World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 2008, http://www.wma.net/e/policy/b3.htm, World Medical Association.
20. Lim E, Winer EP. Adjuvant chemotherapy in luminal breast cancers. Breast 2011, 20(Suppl 3):128-131.
21. Schmitt M, Harbeck N, Brünner N, Jänicke F, Meisner C, Mühlenweg B, Jansen H, Dorn J, Nitz U, Kantelhardt EJ, Thomssen C. Cancer therapy trials employing level-of-evidence-1 disease forecast cancer biomarkers uPA and its inhibitor PAI-1. Expert Rev Mol Diagn 2011, 11(6):617-634. 10.1586/erm.11.47, 21745015.
22. Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP, Watson D, Geyer CE, Wickerham DL, Wolmark N. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol 2010, 28(10):1677-1683. 10.1200/JCO.2009.23.7610, 2849763, 20065188.
23. Dowsett M, Smith I, Robertson J, Robison L, Pinhel I, Johnson L, Salter J, Dunbier A, Anderson H, Ghazoui Z, Skene T, Evans A, A'Hern R, Iskender A, Wilcox M, Bliss J. Endocrine therapy, new biologicals, and new study designs for presurgical studies in breast cancer. J Natl Cancer Inst Monogr 2011, 43:120-123.
24. Gluz O, Kreipe HH, Degenhardt T, Kates R, Liedtke C, Shak S, Clemens M, Markmann S, Uleer C, Augustin D, Thomssen C, Nitz U, Harbeck N, . on behalf of the planB investigators Prospective comparison of risk assessment tools in early breast cancer (Recurrence Score, uPA/PAI-1, central grade, and luminal subtypes): final correlation analysis from the phase III WSG-Plan B trial. San Antonio Breast Cancer Symposium 2011, Cancer Res 2011, 71(24 Supplement):S4-3. on behalf of the planB investigators.
25. Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, Hudis C, Gray JW, Perou C, Yau C, Livasy C, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, Van 't Veer L, Hylton N. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL-CALGB 150007/150012, ACRIN 6657. J Clin Oncol 2012, 30(26):3242-3249. 10.1200/JCO.2011.39.2779, 22649152.
26. Huober J, von Minckwitz G, Denkert C, Tesch H, Weiss E, Zahm DM, Belau A, Khandan F, Hauschild M, Thomssen C, Högel B, Darb-Esfahani S, Mehta K, Loibl S. Effect of neoadjuvant anthracycline-taxane-based chemotherapy in different biological breast cancer phenotypes: overall results from the GeparTrio study. Breast Cancer Res and Treat 2010, 124(1):133-140.
27. von Minckwitz G, Blohmer JU, Costa S, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kümmel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. S3-2: Neoadjuvant Chemotherapy Adapted by Interim Response Improves Overall Survival of Primary Breast Cancer Patients - Results of the GeparTrio Trial. Cancer Res 2011, 71(24 Supplement):S3-2.
28. von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012, 30:1796-1804. 10.1200/JCO.2011.38.8595, 22508812.