A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT02340221
Trial Phases:	Phase III	Protocol IDs:	GO29058 (primary) 2014-003185-25
Eligibility:	18 Years and older, Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT02340221

Summary

This international, multicenter, randomized, double-blinded, placebo-controlled study is
designed to compare the efficacy and safety of taselisib + fulvestrant with that of
placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human
epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally
advanced or metastatic breast cancer after recurrence or progression during or after an
aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm
versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant
tumors via central testing. The anticipated duration of the study is approximately 3.5
years.

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