Table 2.
Summary of phases II-III trials with PI3K isoform specific-inhibitors in HR-positive/HER2-negative metastatic breast cancer.
| Trial | Phase | Patient Population | Targeted Therapy | Treatment | mPFS (Months) |
mOS (Months) |
Orr (%) |
|
|---|---|---|---|---|---|---|---|---|
| Wild Type PI3KCA |
Mutated PIK3CA | Mutated PIK3CA | Mutated PIK3CA | |||||
| SOLAR-1 (Andrè) [69,70] NCT02437318 |
III | HR+/HER2− MBC, resistant to AI | PI3Kα inhibitor |
Alpelisib + Fulvestrant | 7.4 (HR 0.85) |
11.0 (HR 0.65) |
39.3 (HR 0.86) |
26.6 |
| Placebo + Fulvestrant |
5.6 | 5.7 | 31.4 | 12.8 | ||||
| SANDPIPER (Baselga)[71] NCT02340221 |
III | HR+/HER2− LABC or MBC, resistant to AI | Taselisib + Fulvestrant | 5.6 (HR 0.69) |
7.4 (HR 0.70) |
NA | 28 | |
| Placebo + Fulvestrant |
4.0 | 5.4 | NA | 11.9 | ||||
| BYLieve (Rugo)[72] NCT03056755 |
II | HR+/HER2− PIK3CA-mutated MBC, after CDKi + ET or CT or ET | Alpelisib + AI +/− LHRHa | - | NA | NA | NA | |
| Alpelisib + Fulvestrant +/− LHRHa | - | 7.5 | NA | 21 | ||||
Abbreviation: HR+: hormone receptor positive, HER2−: human epidermal growth factor receptor 2 negative, LABC: locally advanced breast cancer; MBC: metastatic breast cancer, AI: aromatase inhibitors, ITT: intention-to-treat, mPFS: progression free survival (months), mOS: overall survival (months), ORR: overall response rate, NA: not available, CDKi: CDK 4/6 inhibitor, ET: endocrine therapy, CT: chemotherapy, LHRHa: luteinizing hormone-releasing hormone agonist.