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

NCT ID NCT05392608

Ongoing Disease control Sponsor: Borstkanker Onderzoek Groep Source: ClinicalTrials.gov ↗

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.

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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.

CONGENITAL, FAMILIAL AND GENETIC DISORDERS NEOPLASM, BREAST

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

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