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. 2021 Sep 28;13(19):4840. doi: 10.3390/cancers13194840

Table 2.

Main characteristics of recent phase III randomized clinical trials.

MINDACT
(n = 6693)
TAILORx
(n = 9719)
WSG-Plan B
(n = 2642)
Study characteristics
Assay MammaPrint © OncotypeDX © OncotypeDX ©
Eligible patients invasive BC, T1-T3, 0–3N+ invasive HR+/HER2− BC, N0,
adjuvant CT indication according to NCCN guidelines
invasive HER2− BC, N+ or high risk (≥T2, grade 2–3, age < 35)
Groups and randomization 4 groups according to Clinical risk (Adjuvant! Online) and Genomic risk (MammaPrint ©):
  • C-low/G-low (41%): no CT

  • C-low/G-high (8.8%): randomized (CT vs. not CT)

  • C-high/G-low (23.2%): randomized (CT vs. not CT)

  • C-high/G-high (27%): CT

3 groups according to OncotypeDX ©:
  • RS ≤ 10 (17%): no CT

  • RS 11–25 (69%): randomized (CT vs. no CT)

  • RS ≥ 26 (14%): CT

3 groups according to OncotypeDX ©:
  • RS ≤ 11 (17.8%): randomized (CT vs. no CT)

  • RS 12–25 (61.4%): CT

  • RS ≥ 26 (20.8%): CT

Primary endpoint 5-year DFMS ≥ 92% for C-high/G-low pts who did not receive CT IDFS non-inferiority of HT alone vs. CT + HT in mid-risk patients IDFS of low-risk patients treated with HT alone
Population main characteristics
Age 32.2% < 50 years 31.4% < 50 years median 56 years
Grade 3 28.8% 17.2% 31.2%
HER2+/TNBC 9.5%/9.6% 0%/0% 0%/2.4%
N+ 21% 0% 35.2% pN1/6% pN2–3

BC, breast cancer; CT, chemotherapy; DFMS, distant metastasis-free survival; HT, hormone therapy; IDFS, invasive disease-free survival; NCCN, national comprehensive cancer network; TNBC, triple-negative breast cancer.