TY - JOUR
T1 - The EORTC 10041/BIG 03-04 MINDACT trial is feasible
T2 - Results of the pilot phase
AU - Rutgers, Emiel
AU - Piccart-Gebhart, Martine J.
AU - Bogaerts, Jan
AU - Delaloge, Suzette
AU - Veer, Laura Van t.L.
AU - Rubio, Isabel Teresa
AU - Viale, Giuseppe
AU - Thompson, Alastair M.
AU - Passalacqua, Rodolfo
AU - Nitz, Ulrike
AU - Vindevoghel, Anita
AU - Pierga, Jean Yves
AU - Ravdin, Peter M.
AU - Werutsky, Gustavo
AU - Cardoso, Fatima
N1 - Funding Information:
E.R., I.T.R., S.D., R.P. and A.V. declare that they have no conflicts of interest. G.W. and J.B. are employees of the EORTC which receives funding for the study. L.V.V. is a founder of Agendia and has stock ownership. G.V. has received consultancy fees/honorarium from Agendia. J.Y.P. has received consultancy fees from Roche and Ipsem, honorarium from Sanofi-Aventis and Pfizer, and research grant from Roche. M.G.P. has received consultancy fees from Sanofi-Aventis, Novartis and Roche, honorarium from Roche and research grant from Roche and Novartis. U.N. has received honorarium from Sanofi-Aventis, Amgen, Roche and Novartis. A.M.T. has received research funds from Sanofi-Aventis and Roche, honoraria from Roche and other funding (e.g. travel, accommodation, meeting expenses) from Novartis and Roche. P.M.R. is a founder of Adjuvant Online Inc. and has consultant and stock ownership. F.C. has received consultancy fees/honorarium from Novartis, Sanofi-Aventis and Roche.
Funding Information:
This trial has funding grants from the European Commission Framework Programme VI ( FP6-LSHC-CT-2004-503426 ), the Breast Cancer Research Foundation, Novartis, F. Hoffman La Roche, Sanofi-Aventis, the National Cancer Institute (NCI), the EBCC-Breast Cancer Working Group, the Jacqueline Seroussi Memorial Foundation, Prix Mois du Cancer du Sein, Susan G. Komen for the Cure, Fondation Belge Contre le Cancer, Dutch Cancer Society (KWF), Association Le Cancer du Sein, Parlons-en!, Deutsche Krebshilfe and the Grant Simpson Trust and Cancer Research UK. Whole genome analysis is provided in kind by Agendia.
PY - 2011/12/1
Y1 - 2011/12/1
N2 - Background: The MINDACT (Microarray In Node-negative and 1-3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. We present the results of the pilot phase consisting of first 800 patients included. Methods: MINDACT has enrolled 6600 patients, classified into high or low risk by MammaPrint and clinicopathological risk through Adjuvant! Online. Patients with both clinical (C) and genomic (G) high risks are offered adjuvant CT; those with both C and G low risks do not receive CT; patients with discordant risk are randomised for the decision of adjuvant CT based on C or G risk. CT randomisation of anthracycline-based versus docetaxel/capecitabine and endocrine therapy randomisation between letrozole and tamoxifen → letrozole are offered. Results: During the pilot phase 46% of screened patients were enrolled. Main reasons for non-enrolment were node positivity before trial amendment, sample quality problems and failure to meet logistic settings. Among the 800 patients, 386 (48%) were C-low/G-low, 198 (24.8%) as C-high/G-high, 75 (9.4%) as C-low/G-high and 141 (17.6%) as C-high/G-low. In total 216 (27%) cases were discordant. The difference between patients with C-high (42%) and G-high risk (34%) is 8.25% (95% confidence interval (CI), 4.7-11.8%; P <.0001). Compliance with the treatment decision was high (>92%). Conclusions: The logistically complex MINDACT trial is feasible in a multinational setting. The proportion of discordant patients, the potential reduction in CT by using the genomic signature and compliance to treatment assignment are in accordance with the trial hypotheses.
AB - Background: The MINDACT (Microarray In Node-negative and 1-3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. We present the results of the pilot phase consisting of first 800 patients included. Methods: MINDACT has enrolled 6600 patients, classified into high or low risk by MammaPrint and clinicopathological risk through Adjuvant! Online. Patients with both clinical (C) and genomic (G) high risks are offered adjuvant CT; those with both C and G low risks do not receive CT; patients with discordant risk are randomised for the decision of adjuvant CT based on C or G risk. CT randomisation of anthracycline-based versus docetaxel/capecitabine and endocrine therapy randomisation between letrozole and tamoxifen → letrozole are offered. Results: During the pilot phase 46% of screened patients were enrolled. Main reasons for non-enrolment were node positivity before trial amendment, sample quality problems and failure to meet logistic settings. Among the 800 patients, 386 (48%) were C-low/G-low, 198 (24.8%) as C-high/G-high, 75 (9.4%) as C-low/G-high and 141 (17.6%) as C-high/G-low. In total 216 (27%) cases were discordant. The difference between patients with C-high (42%) and G-high risk (34%) is 8.25% (95% confidence interval (CI), 4.7-11.8%; P <.0001). Compliance with the treatment decision was high (>92%). Conclusions: The logistically complex MINDACT trial is feasible in a multinational setting. The proportion of discordant patients, the potential reduction in CT by using the genomic signature and compliance to treatment assignment are in accordance with the trial hypotheses.
KW - Breast cancer
KW - Chemotherapy
KW - Endocrine therapy
KW - Gene expression signatures
KW - Genomics
KW - MammaPrint™
KW - Pilot study
UR - http://www.scopus.com/inward/record.url?scp=82255175550&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2011.09.016
DO - 10.1016/j.ejca.2011.09.016
M3 - Article
C2 - 22051734
AN - SCOPUS:82255175550
SN - 0959-8049
VL - 47
SP - 2742
EP - 2749
JO - European Journal of Cancer
JF - European Journal of Cancer
IS - 18
ER -