drugset / Trial / NCT02756364

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

NCT02756364

Phase 2 Completed 141 enrolled Calithera Biosciences, Inc
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Sapanisertib Small molecule 4 mg Oral
Subject Sapanisertib Small molecule 30 mg Oral

Indications