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New drug combo targets genetic weakness in advanced breast cancer

NCT ID NCT04524000

Ongoing Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

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.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BREAST CANCER

Contacts and locations

Locations

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4648681, 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

    Kumamoto, Kumamoto, 860-8556, 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, 1358550, Japan

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 152-8902, Japan

  • Novartis Investigative Site

    Niigata, 951-8566, Japan

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