Language and content disclaimer
The content and search results on this site are collected from or provided by third parties. As such some of the information may only be available in the language originally submitted by the sponsor of the trial. Learn more about the information on the search portal.
Linking to Non-Government of Canada Websites
Links to websites not under the control of the Government of Canada, including those to our social media accounts, and to clinical trial records in international registries are provided solely for the convenience of our website visitors. We are not responsible for the accuracy, currency or reliability of the content of such websites. The Government of Canada does not offer any guarantee in that regard and is not responsible for the information found through these links, nor does it endorse the sites and their content.
Visitors should also be aware that information offered by non-Government of Canada sites to which this website links is not subject to the Privacy Act or the Official Languages Act and may not be accessible to persons with disabilities. The information offered may be available only in the language(s) used by the sites in question. With respect to privacy, visitors should research the privacy policies of these non-government websites before providing personal information.
View trial details
Overview
Official protocol title:
EPIK-B5: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPELISIB IN COMBINATION WITH FULVESTRANT FOR MEN AND POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH A PIK3CA MUTATION, WHO PROGRESSED ON OR AFTER AROMATASE INHIBITOR AND A CDK4/6 INHIBITOR
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.
PIQRAY
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'.
CBYL719C2303
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
256853
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.
November 04, 2021
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 -
NCT05038735
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 5G2
Ontario
Novartis Investigative Site
