New pill combo aims to keep advanced breast cancer in check
NCT ID NCT04208178
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 study tests whether adding the targeted drug alpelisib to standard maintenance therapy (trastuzumab and pertuzumab) can help people with advanced HER2-positive breast cancer that has a specific genetic change (PIK3CA mutation) live longer without their cancer growing. The trial enrolls about 19 participants who have already received initial chemotherapy. Part 1 checks the safety of the combination, and Part 2 compares alpelisib against a placebo.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
alpelisib (a targeted cancer pill)
What this could lead to
If successful, this could offer a new maintenance treatment option to help delay cancer progression in people with a specific genetic mutation.
What could go wrong
This is a small, early-phase safety run-in (Part 1) followed by a randomized Phase 3. The drug may cause side effects or not improve outcomes compared to placebo.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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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.
Contacts and locations
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Locations
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Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
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Novartis Investigative Site
Leuven, 3000, Belgium
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Novartis Investigative Site
Liège, 4000, Belgium
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Novartis Investigative Site
Changchun, Jilin, 130021, China
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Novartis Investigative Site
Shanghai, 200032, China
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Novartis Investigative Site
Saint-Cloud, Hauts De Seine, 92210, France
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Novartis Investigative Site
Saint-Herblain, 44805, France
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Novartis Investigative Site
Florence, FI, 50134, Italy
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Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
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Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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University of California LA
Los Angeles, California, 90095, United States