Alpelisib's Long-Term safety tracked in PIK3CA patients
NCT ID NCT07679269
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study provides continued access to alpelisib for people who are already benefiting from it in a previous Novartis trial. It focuses on tracking long-term safety, including any side effects, in participants with PIK3CA-related overgrowth spectrum or certain breast cancers. Participants take alpelisib alone or with other drugs like fulvestrant or trastuzumab, and doctors regularly check whether the treatment still helps them.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Alpelisib (BYL719), sometimes combined with fulvestrant, trastuzumab, or pertuzumab
- What this could lead to
- If successful, this study could confirm that alpelisib is safe enough for long-term use, supporting its continued availability for people with PIK3CA-related conditions.
- What could go wrong
- This is a small, open-label roll-over study focused on safety, not on proving new benefits. Side effects may still emerge, and results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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