Table 1.

Ongoing clinical trials with PI3K pathway inhibitors that include a TNBC cohort (clinicaltrials.gov)

TargetStudy drugsDesignNaBreast subtypeIdentifier
mTOR InhibitorsTemsirolimus + cisplatin/erlotinibPhase I18MBC TNBCNCT00998036
Temsirolimus + peg-liposomal doxorubicinPhase I30MBCNCT00982631
Temsirolimus + neratinibPhase I/II65MBC TNBC or Her2+NCT01111825
Temsirolimus + IMC-A12Phase I/II68MBCNCT00699491
Everolimus + abraxanePhase I/II72MBC Her2NCT00934895
Everolimus + lapatinibPhase II43MBC TNBCNCT01272141
Everolimus + FEC/paclitaxelPhase II62Neoadjuvant stage II–III TNBCNCT00499603
EverolimusPhase II50Neoadjuvant stage I–III after chemotherapyNCT01088893
Everolimus + cisplatin/paclitaxelPhase II120Neoadjuvant stage II–III TNBCNCT00930930
Pan PI3K inhibitorsGDC-0941 + paclitaxel/bevacizumabPhase I24Locally recurrent or MBCNCT00960960
BKM120 + olaparibPhase I56TNBC or high-grade serous ovarian cancerNCT01623349
BKM120Phase II50MBC TNBCNCT01629615
Dual PI3K + mTOR inhibitorsBEZ235 + paclitaxelPhase I/II230MBC Her2NCT01495247
AKT InhibitorsMK2206Phase II30Neoadjuvant stage I–IIINCT01319539
MK2206Phase II40MBC with PIK3CA mutation or PTEN lossNCT01277757

NOTE: This list is restricted to currently recruiting trials.

Abbreviations: FEC, 5-fluorouracil, etoposide, and cyclophosphamide; MBC, metastatic breast cancer.

  • aN represents the goal for recruitment.