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View trial details
Overview
Official protocol title:
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE EFFICACY AND SAFETY OF RIBOCICLIB WITH ENDOCRINE THERAPY AS AN ADJUVANT TREATMENT IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE, EARLY BREAST CANCER (NEW ADJUVANT TRIALWITH RIBOCICLIB [LEE011]: NATALEE).
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
RIBOCICLIB (LEE011) / LETROZOLE / ANASTROZOLE / GOSERELIN
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
CLEE011O12301C
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
223885
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Active, not recruiting
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
February 19, 2019
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
ClinicalTrials.gov -
NCT03701334
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Accepts healthy volunteers:
No
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
North Vancouver, British Columbia, V7L 2L7
Novartis Investigative Site
Surrey, British Columbia, V3V 1Z2
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6
Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Ontario
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 5J1
Novartis Investigative Site
Kitchener, Ontario, N2G 1G3
Novartis Investigative Site
Novartis Investigative Site
Newmarket, Ontario, J7Y 2P9
Novartis Investigative Site
Novartis Investigative Site
Sault Ste. Marie, Ontario, P6B 0A8
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Novartis Investigative Site
Windsor, Ontario, N8W 2X3
Quebec
Novartis Investigative Site
Fleurimont, Quebec, J1H 5N4
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2H1
Novartis Investigative Site
Montreal, Quebec, H2W 1T8
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Montreal, Quebec, H4A 3J1
Novartis Investigative Site
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 5T3
