Table 2 Ongoing clinical trials recruiting breast cancer patients with PIK3CA mutations
From: PIK3CA mutations in breast cancer: reconciling findings from preclinical and clinical data
Agent | Class | Trial | Description | Patients (n) |
|---|---|---|---|---|
BYL719 | α-Selective PI3K inhibitor | Phase I (NCT01219699) | Dose escalation in combination with fulvestrant | Postmenopausal women with MBC (160) |
Phase Ib/II (NCT01708161) | Dose escalation in combination with AMG479 | Advanced solid tumors (70) | ||
BKM120 | Pan-PI3K inhibitor | Phase I/II (NCT01589861) | Dose escalation in combination with lapatinib | HER2-positive, trastuzumab-resistant MBC (106) |
MK2206 | AKT inhibitor | Phase II (NCT01277757) | Safety and efficacy of MK2206 monotherapy | Advanced breast cancer (40) |
Phase II (NCT01776008) | Safety and efficacy of MK2206 and anastrozole with or without goserelin in the neoadjuvant setting | ER-positive breast cancer, stage II to IIIC (87) | ||
AZD5363 | AKT inhibitor | Phase I (NCT01226316) | Dose escalation | Advanced solid tumors and MBC (107) |
Phase I (NCT01625286) | Dose escalation in combination with paclitaxel | ER-positive MBC (110) |