Table 3 Randomized Window-of-opportunity trials with molecularly targeted agents in patients with early-stage breast cancer

From: Window-of-opportunity trials to screen effective agents and optimize dose in breast cancer prevention

Author, Year [Reference]

Size

Study drug

Comparator

Duration of Treatment (days)

Findings

Garwood (2010)78

29

Fluvastatin 20 mg/day

Fluvastatin 80 mg/day

21–42

Fluvastatin reduced Ki-67 of high-grade tumors (p = 0.008); no difference between Fluvastatin 20 or 80 mg by Ki67 changes

Martin (2010)79

23

Celecoxib 400 mg/day

No treatment

14

−16.6% Ki-67 reduction under celecoxib (p = 0.056)

DeCensi (2011)75

60

Lapatinib 1500 mg/day

Placebo

21

9% reduction in Ki-67 after lapatinib (p = 0.008) in HER2+ breast cancer

Leary (2015)76

121

Lapatinib 1500 mg/day

Placebo

10–14

↓Ki-67 with Lapatinib (p < 0.001), both in HER2+ (p = 0.003) and HER2- (p = 0.017)

Robertson (2020)77

48

Capivasertib

Placebo

4.5

Capivasertib decreases Ki67