New drug combo aims to stall breast cancer in patients with key gene mutation
NCT ID NCT04544189
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II study tests whether adding alpelisib (a targeted pill) to standard fulvestrant (a hormone-blocking shot) can delay cancer growth in Chinese men and postmenopausal women with a specific type of advanced breast cancer (HR+, HER2-, with a PIK3CA mutation) that has worsened after prior hormone therapy. About 69 participants will receive either the drug combo or a placebo plus fulvestrant. The main goal is to see how long the cancer stays under control.
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) combined with fulvestrant (a hormone-blocking injection)
- What this could lead to
- If successful, this combination could offer a new treatment option that delays cancer progression for Chinese patients with a specific genetic mutation (PIK3CA) whose breast cancer has worsened after standard hormone therapy.
- What could go wrong
- This is a relatively small phase II trial (69 participants), so results may not apply broadly. The drug combination may cause side effects like high blood sugar or rash, and it is not yet proven to improve survival.
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.
Contacts and locations
Locations
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Novartis Investigative Site
Hefei, Anhui, 230001, China
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Novartis Investigative Site
Hefei, Anhui, 230031, China
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Novartis Investigative Site
Guangzhou, Guangdong, 510000, China
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Novartis Investigative Site
Shijiazhuang, Hebei, 050011, China
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Novartis Investigative Site
Harbin, Heilongjiang, 150081, China
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Novartis Investigative Site
Zhengzhou, Henan, 450008, China
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Novartis Investigative Site
Wuhan, Hubei, 430022, China
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Novartis Investigative Site
Changsha, Hunan, 410013, China
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Novartis Investigative Site
Nanjing, Jiangsu, 210009, China
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Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
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Novartis Investigative Site
Nanchang, Jiangxi, 330009, China
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Novartis Investigative Site
Changchun, Jilin, 130021, China
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Novartis Investigative Site
Shengyang, Liaoning, 110042, China
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Novartis Investigative Site
Shenyang, Liaoning, 110011, China
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Novartis Investigative Site
Jinan, Shandong, 250117, China
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Novartis Investigative Site
Chengdu, Sichuan, 610041, China
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Novartis Investigative Site
Hangzhou, Zhejiang, 310016, China
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Novartis Investigative Site
Hangzhou, Zhejiang, 310022, China
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Novartis Investigative Site
Beijing, 100021, China
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Novartis Investigative Site
Bengbu, 233004, China
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Novartis Investigative Site
Dalian, 116000, China
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Novartis Investigative Site
Qingdao, 266000, China
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Novartis Investigative Site
Shanghai, 200025, China
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Novartis Investigative Site
Tianjin, 300480, China
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Other studies related to the condition(s) this trial covers.
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