Phase 2 Breast Cancer Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- The participant (and/or their parent or legal guardian) has signed a consent form agreeing to take part, following local guidelines, before joining this follow-on study.
- The participant is currently enrolled in an existing Novartis-sponsored study, is receiving alpelisib either alone or combined with other drugs, and has completed all required treatment steps in that original study.
- The participant's doctor (the Investigator) has determined that the participant is currently benefiting from alpelisib treatment in the original study.
- The participant has kept up with required visits in the original study and, in the Investigator's opinion, has shown the willingness and ability to follow future visit schedules, treatment plans, and other study requirements.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- The participant permanently stopped taking alpelisib in the original study for any reason, including choosing to withdraw consent.
- The participant currently has ongoing or unresolved side effects rated Grade 3 or higher, or any ongoing side effects that caused alpelisib dosing to be paused in the original study (though people who otherwise meet all criteria may be considered once side effects have improved enough for dosing to resume, as set out in the original study).
- The participant's current treatment is already government-approved and covered by their country's health system for their condition (in exceptional cases where it is covered nationally but not for a specific individual, the Novartis Study Team should be contacted).
- The participant is currently taking part in any other experimental clinical trial besides the original Novartis-sponsored study.
- The participant is pregnant or currently breastfeeding.
- Female participants who are able to become pregnant and do not agree to use a highly effective form of contraception, and male participants who do not agree to use a condom and/or a highly effective form of contraception — including avoiding sperm donation and taking steps to prevent a partner being exposed to alpelisib through seminal fluid — for the entire duration of the study and for at least one week after stopping alpelisib (or longer if the original study requires it).
- Other criteria set by the trial may also apply (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Phone: 1-888-669-6682
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.