New combo targets Gene-Mutated breast cancer after first treatment fails

NCT ID NCT05392608

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding alpelisib to continued fulvestrant can help people with advanced, hormone-receptor-positive, HER2-negative breast cancer that has a PIK3CA mutation. Participants have already seen their cancer progress while on fulvestrant. The study aims to see how long the combination can control the cancer. 130 adults are enrolled across multiple centers in the Netherlands.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Alpelisib (Piqray) and fulvestrant (Faslodex)

What this could lead to

If successful, this could offer a new treatment option for people with a specific genetic mutation in advanced breast cancer, potentially delaying further disease progression.

What could go wrong

This is an early-phase, single-arm study with no comparison group, so results may not be definitive. Side effects from alpelisib can be significant, and the benefit may be limited to a subset of patients.

Disclaimer Read more

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.

breast neoplasm hereditary disease hormone receptor-positive breast cancer

As listed by the trial registrant

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

Contacts and locations

Locations

  • Admiraal de Ruyter Ziekenhuis

    Goes, Netherlands

  • Amphia

    Breda, Netherlands

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Antoni van Leeuwenhoek

    Amsterdam, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Netherlands

  • Deventer ziekenhuis

    Deventer, Netherlands

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, Netherlands

  • Franciscus Gasthuis & Vlietland

    Schiedam, Netherlands

  • Gelre Ziekenhuizen

    Apeldoorn, Netherlands

  • HagaZiekenhuis

    The Hague, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Máxima Medisch Centrum

    Eindhoven, Netherlands

  • Noordwest Ziekenhuisgroep

    Alkmaar, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Rijnstate

    Arnhem, Netherlands

  • Spaarne Gasthuis

    Hoofddorp, Netherlands

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • VieCuri Medisch Centrum

    Venlo, Netherlands

  • Ziekenhuis Amstelland

    Amstelveen, Netherlands

  • Ziekenhuisgroep Twente

    Almelo, Netherlands