A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
Inclusion Criteria
Exclusion Criteria
Buenos Aires, Ciudad Autónoma de BuenosAires C1113AAE, Argentina
Ciudad Autonoma Buenos Aires, C1426AGE, Argentina
London, Ontario N6A 4L6, Canada
Clermont-Ferrand, 63003, France
Sarawak, Sarawak 93586, Malaysia
Moscow, Moscow Oblast 111123, Russia
Moscow, Moscow Oblast 115552, Russia
Moscow, Moscow Oblast 143422, Russia
Moskva, Moscow Oblast 119421, Russia
Kharkiv, Kharkiv Governorate 61018, Ukraine
Ivano-Frankivsk, KIEV Governorate 76018, Ukraine