New drug combo targets genetic weakness in advanced breast cancer
NCT ID NCT04524000
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a combination of two drugs—alpelisib (a targeted therapy) and fulvestrant (a hormone blocker)—in Japanese men and postmenopausal women with a specific type of advanced breast cancer (HR+/HER2-) that has a PIK3CA mutation. The cancer must have worsened after prior hormone therapy. The trial has two parts: first to find the safest dose, then to measure how well the combo shrinks tumors. Only 24 participants are enrolled, so results are preliminary.
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 drug) combined with fulvestrant (a hormone therapy)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with a specific genetic mutation (PIK3CA) whose advanced breast cancer has stopped responding to standard hormone therapy.
What could go wrong
This is a small, early-phase trial (24 participants) focused on safety and dosing, so it is too soon to know if the combination works better than existing options. Side effects from alpelisib, such as high blood sugar and rash, are possible.
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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Novartis Investigative Site
Nagoya, Aichi-ken, 4648681, Japan
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Novartis Investigative Site
Nagoya, Aichi-ken, 4668560, Japan
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Novartis Investigative Site
Nagoya, Aichi-ken, 4678602, Japan
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Novartis Investigative Site
Kashiwa, Chiba, 277-8577, Japan
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Novartis Investigative Site
Isehara, Kanagawa, 259-1193, Japan
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Novartis Investigative Site
Yokohama, Kanagawa, 241-8515, Japan
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Novartis Investigative Site
Kumamoto, Kumamoto, 860-8556, Japan
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Novartis Investigative Site
Sendai, Miyagi, 9808574, Japan
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Novartis Investigative Site
Osaka, Osaka, 5400006, Japan
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Novartis Investigative Site
Osaka, Osaka, 5418567, Japan
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Novartis Investigative Site
Suita, Osaka, 565-0871, Japan
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Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677, Japan
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Novartis Investigative Site
Koto Ku, Tokyo, 1358550, Japan
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Novartis Investigative Site
Meguro-ku, Tokyo, 152-8902, Japan
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Novartis Investigative Site
Niigata, 951-8566, Japan