Viewing Study NCT03839823



Ignite Creation Date: 2024-05-06 @ 12:43 PM
Last Modification Date: 2024-10-26 @ 1:03 PM
Study NCT ID: NCT03839823
Status: COMPLETED
Last Update Posted: 2023-06-26
First Post: 2019-01-24

Brief Title: Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official Title: A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
Status: COMPLETED
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RIGHT Choice
Brief Summary: To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
Detailed Description: Patients were randomly assigned to one of the below treatment arms in 11 ratio

Ribociclib arm non-steroidal aromatase inhibitor NSAI goserelin Ribociclib
Combination chemotherapy arm Either of docetaxel capecitabine paclitaxel gemcitabine or capecitabine vinorelbine based chemotherapy treatment Randomization was stratified by 1 the presence of liver metastases present or absent 2 disease-free interval DFI 2 years yes or no de novo stage 4 was defined as DFI 2 years

The study consisted of a 28-day Screening phase treatment phase including end of treatment EOT visit and safety follow-up and survival follow-up Patients received study treatment until disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason

Patients were followed for survival regardless of treatment discontinuation for any reason except if consent was withdrawn patient was lost to follow-up or until death and regardless of achieving the primary endpoint until death withdrawal of consent or loss to follow-up

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None