Randomized clinical trials investigating the clinical utility of Ki67 and PEPI scores
Study | Profile | Initial treatment | Randomization | Primary endpoint(s) |
---|---|---|---|---|
NCT01953588 | Phase IIb–III (n = 2820) | A: Anastrozole | 4/12 weeks | Modified PEPI + Ki67 at 4/12 weeks |
ALTERNATE | T2–T4 | B: Fulvestrant | Ki67 <10% → ET × 24 weeks | |
Allred 6–8 | C: Fulvestrant + anastrozole | Ki67 >10% → CT × 24 weeks | ||
After surgery | ||||
PEPI 0 → ET × 5 years | ||||
NCT00265759 | Phase III (n = 610) | A: Anastrozole | 2–4 weeks | ORR |
ACOSOG Z1031-B | Stage II–III | B: Exemestane | Ki67 <10% → ET | pCR for CT arm |
Allred 6–8 | C: Letrozole | Ki67 >10% → CT or surgery | ||
After surgery | ||||
PEPI 0 → ET alone | ||||
NCT01779206 | Phase III (n = 4,000) | ET | 3 weeks | RFS |
ADAPT HR+/HER2− | N0-1 and Oncotype RS 12–25 | Ki67 <10% → ET | ||
Ki67 >10% → CT | ||||
NCT02592083 | Phase II (n = 200) | ET | 4 weeks | ORR at 16 weeks |
PREDIX-A | Pre- and postmenopausal | Ki67 decrease ≥20%:
| ||
Luminal A: ER ≥50% and Ki67 ≤20% | Ki67 decrease <20%:
| |||
NCT02603679 | Phase II (n = 200) | A: Paclitaxel | 12 weeks | ORR at 24 weeks |
PREDIX-B | Luminal B or Luminal A (Ki67 >20%) and age <40 years or N1 | B: ET + palbociclib | If not progressive disease:
| |
NCT01613560 | Phase II (n = 404) | ET | 16–20 weeks | RFS |
T2–3 | PEPI 0–1 → ET × 5 years | |||
ER or PR >50% | PEPI 2–4 → randomized to:
|
Abbreviations: CT, chemotherapy; ET, endocrine therapy,