NCT03671330 - Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. | Biotech Hunter

Enrollment

327

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

April 25, 2022

Study Completion Date

May 9, 2025

Conditions

Breast Cancer

Interventions

DRUG

Ribociclib Placebo

Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.

DRUG

Ribociclib

Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.

DRUG

NSAI: Letrozole or Anastrazole

"Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).~Anastrazole: Tablets for oral use, 1mg daily (all days of every cycle without interruption) For Premenopausal cohort, it is the investigators choice for NSAI based on patients past history.~For postmenopausal and PK cohorts, all patients will be on Letrozole."

DRUG

Letrozole

Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).

DRUG

Goserelin

Subcutaneous implant, 3.6mg on Day 1 of each 28 day cycle

Trial Locations (24)

100036

Novartis Investigative Site, Beijing

100044

Novartis Investigative Site, Beijing

110016

Novartis Investigative Site, Shengyang

110042

Novartis Investigative Site, Shengyang

130021

Novartis Investigative Site, Changchun

150081

Novartis Investigative Site, Harbin

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

210029

Novartis Investigative Site, Nanjing

215004

Novartis Investigative Site, Suzhou

230001

Novartis Investigative Site, Hefei

266000

Novartis Investigative Site, Qingdao

300480

Novartis Investigative Site, Tianjin

310006

Novartis Investigative Site, Hangzhou

310016

Novartis Investigative Site, Hangzhou

330009

Novartis Investigative Site, Nanchang

350001

Novartis Investigative Site, Fuzhou

404100

Novartis Investigative Site, Chongqing

410013

Novartis Investigative Site, Changsha

510000

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

650106

Novartis Investigative Site, Kunming

710061

Novartis Investigative Site, Xian

050011

Novartis Investigative Site, Shijiazhuang