Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

Last updated:
2026-07-11
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View trial details

Overview

Official protocol title:

AN OPEN-LABEL, MULTICENTER, PHASE IIIB STUDY TO ASSESS THE SAFETY AND EFFICACY OF RIBOCICLIB (LEE011) IN COMBINATION WITH LETROZOLE FOR THE TREATMENT OF MEN AND POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE (HR+) HER2-NEGATIVE (HER2-) ADVANCED BREAST CANCER (ABC) WITH NO PRIOR HORMONAL THERAPY FOR ADVANCED DISEASE

Intervention/treatment:
RIBOCICLIB (LEE011)/ FLUDEOXYGLUCOSE 18F/ TECHNETIUM TC 99M/ SODIUM FLUORIDE 18F
Medical condition:
BREAST CANCER
Protocol code:
CLEE011A2404
Control number:
199825
Status:
Closed
Approved:
December 15, 2016
Date Completed:
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT02941926
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
18 Years and older
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Study director
Organization
Novartis Pharmaceuticals
Phone:
+ 1 862 778 8300
Sponsor
NOVARTIS PHARMACEUTICALS CANADA INC

Locations

Alberta

Novartis Investigative Site
Calgary, Alberta, T2N 4N2
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2

British Columbia

Novartis Investigative Site
Kelowna, British Columbia, V1Y 5L3
Novartis Investigative Site
Surrey, British Columbia, V3V 1Z2
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6

Manitoba

Novartis Investigative Site
Winnipeg, Manitoba, R3E 0V9

New Brunswick

Novartis Investigative Site
Moncton, New Brunswick, E1C 6Z8

Nova Scotia

Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9

Ontario

Novartis Investigative Site
Barrie, Ontario, L4M 6M2
Novartis Investigative Site
Cambridge, Ontario, N1R 3G2
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 5J1
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
Kingston, Ontario, K7L 5P9
Novartis Investigative Site
Kitchener, Ontario, N2G 1G3
Novartis Investigative Site
London, Ontario, N6A 4G4
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P9
Novartis Investigative Site
North York, Ontario, M2K1E1
Novartis Investigative Site
Oshawa, Ontario, L1G 2B9
Novartis Investigative Site
Ottawa, Ontario, KIH 7W9
Novartis Investigative Site
Sault Ste. Marie, Ontario, P6B 0A8
Novartis Investigative Site
Toronto, Ontario, M3M 0B2
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, M5B 1W8

Quebec

Novartis Investigative Site
Greenfield Park, Quebec, J4V 2H1
Novartis Investigative Site
Laval, Quebec, H7M 3L9
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Montreal, Quebec, H3T 1M5
Novartis Investigative Site
Montreal, Quebec, H4J 1C5
Novartis Investigative Site
Québec, Quebec, G1S 4L8
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4

Saskatchewan

Novartis Investigative Site
Regina, Saskatchewan, S4T 7T1
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 4H4

Results

See the results from the trial NCT02941926. This is an external link. The information is not authorized by the Government of Canada.

Date posted:
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