NCT04544189 - Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 20, 2021

Primary Completion Date

March 2, 2026

Study Completion Date

March 2, 2026

Conditions

Breast Neoplasms

Interventions

DRUG

Alpelisib

300mg (oral) once daily, in a 28-day cycle

DRUG

Fulvestrant

Fulvestrant 500 mg (intramuscular, as two 250mg/5 mL injections) on Day 1 and 15 of Cycle 1 and on Day 1 of every Cycle thereafter

DRUG

Placebo

300 mg by mouth once daily, in a 28-day cycle

Trial Locations (24)

100021

Novartis Investigative Site, Beijing

110011

Novartis Investigative Site, Shenyang

110042

Novartis Investigative Site, Shengyang

116000

Novartis Investigative Site, Dalian

130021

Novartis Investigative Site, Changchun

150081

Novartis Investigative Site, Harbin

200025

Novartis Investigative Site, Shanghai

210009

Novartis Investigative Site, Nanjing

210029

Novartis Investigative Site, Nanjing

230001

Novartis Investigative Site, Hefei

230031

Novartis Investigative Site, Hefei

233004

Novartis Investigative Site, Bengbu

250117

Novartis Investigative Site, Jinan

266000

Novartis Investigative Site, Qingdao

300480

Novartis Investigative Site, Tianjin

310016

Novartis Investigative Site, Hangzhou

310022

Novartis Investigative Site, Hangzhou

330009

Novartis Investigative Site, Nanchang

410013

Novartis Investigative Site, Changsha

430022

Novartis Investigative Site, Wuhan

450008

Novartis Investigative Site, Zhengzhou

510000

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

050011

Novartis Investigative Site, Shijiazhuang