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

Emiel Rutgers, Martine J. Piccart-Gebhart, Jan Bogaerts, Suzette Delaloge, Laura Van t L Veer, Isabel Teresa Rubio, Giuseppe Viale, Alastair M. Thompson, Rodolfo Passalacqua, Ulrike Nitz, Anita Vindevoghel, Jean Yves Pierga, Peter M. Ravdin, Gustavo Werutsky, Fatima Cardoso

Research output: Contribution to journalArticle

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Abstract

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 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.

Original languageEnglish
Pages (from-to)2742-2749
Number of pages8
JournalEuropean Journal of Cancer
Volume47
Issue number18
DOIs
Publication statusPublished - Dec 2011

Fingerprint

letrozole
Adjuvant Chemotherapy
Drug Therapy
docetaxel
Random Allocation
Anthracyclines
Tamoxifen
Clinical Trials
Confidence Intervals
Breast Neoplasms
Therapeutics
Genes

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Rutgers, E., Piccart-Gebhart, M. J., Bogaerts, J., Delaloge, S., Veer, L. V. T. L., Rubio, I. T., ... Cardoso, F. (2011). The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase. European Journal of Cancer, 47(18), 2742-2749. https://doi.org/10.1016/j.ejca.2011.09.016

The EORTC 10041/BIG 03-04 MINDACT trial is feasible : Results of the pilot phase. / Rutgers, Emiel; Piccart-Gebhart, Martine J.; Bogaerts, Jan; Delaloge, Suzette; Veer, Laura Van t L; Rubio, Isabel Teresa; Viale, Giuseppe; Thompson, Alastair M.; Passalacqua, Rodolfo; Nitz, Ulrike; Vindevoghel, Anita; Pierga, Jean Yves; Ravdin, Peter M.; Werutsky, Gustavo; Cardoso, Fatima.

In: European Journal of Cancer, Vol. 47, No. 18, 12.2011, p. 2742-2749.

Research output: Contribution to journalArticle

Rutgers, E, Piccart-Gebhart, MJ, Bogaerts, J, Delaloge, S, Veer, LVTL, Rubio, IT, Viale, G, Thompson, AM, Passalacqua, R, Nitz, U, Vindevoghel, A, Pierga, JY, Ravdin, PM, Werutsky, G & Cardoso, F 2011, 'The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase', European Journal of Cancer, vol. 47, no. 18, pp. 2742-2749. https://doi.org/10.1016/j.ejca.2011.09.016
Rutgers E, Piccart-Gebhart MJ, Bogaerts J, Delaloge S, Veer LVTL, Rubio IT et al. The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase. European Journal of Cancer. 2011 Dec;47(18):2742-2749. https://doi.org/10.1016/j.ejca.2011.09.016
Rutgers, Emiel ; Piccart-Gebhart, Martine J. ; Bogaerts, Jan ; Delaloge, Suzette ; Veer, Laura Van t L ; Rubio, Isabel Teresa ; Viale, Giuseppe ; Thompson, Alastair M. ; Passalacqua, Rodolfo ; Nitz, Ulrike ; Vindevoghel, Anita ; Pierga, Jean Yves ; Ravdin, Peter M. ; Werutsky, Gustavo ; Cardoso, Fatima. / The EORTC 10041/BIG 03-04 MINDACT trial is feasible : Results of the pilot phase. In: European Journal of Cancer. 2011 ; Vol. 47, No. 18. pp. 2742-2749.
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abstract = "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 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.",
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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

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KW - Endocrine therapy

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