New drug combo targets Gene-Mutated breast cancer in japanese patients

NCT ID NCT04524000

First seen Nov 01, 2025 · Last updated May 13, 2026 · Updated 27 times

Summary

This study tests a combination of two drugs, alpelisib and fulvestrant, in Japanese men and postmenopausal women with a certain type of advanced breast cancer (HR+, HER2-) that has a PIK3CA gene change and has stopped responding to hormone therapy. The goal is to see if the combination is safe and effective at shrinking tumors. About 24 participants will receive the treatment, and researchers will monitor side effects and tumor response.

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Contacts and locations

Locations

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4678602, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8577, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5400006, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5418567, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565-0871, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138677, Japan

  • Novartis Investigative Site

    Koto Ku, Tokyo, 135-8550, Japan

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 152-8902, Japan

  • Novartis Investigative Site

    Kumamoto, 860-8556, Japan

  • Novartis Investigative Site

    Niigata, 951-8566, Japan

Conditions

Explore the condition pages connected to this study.