Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy

Summary

The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants treated with single-agent fulvestrant.

Timeline

Start

2016-07-28

Primary completion

2019-11-25

Completion

2019-11-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A: Fulvestrant 500 mg vs Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD; p = 0.537 NCT02756364 ↗

registry analysis (superiority test); Arm A: Fulvestrant 500 mg vs Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW; p = 0.849 NCT02756364 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Subject	Sapanisertib	Small molecule	4 mg	Oral
Subject	Sapanisertib	Small molecule	30 mg	Oral

Indications