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

NCT ID NCT05392608

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult women and men (≥ 18 years of age) with proven diagnosis of adenocarcino-ma of the breast withlocoregional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent andfor whom chemotherapy is not clinically indicated * Estrogen receptor (ER) expression \>10% and/or progesterone receptor (PR) expression \>10% breast cancerbased on local la-boratory results. Tumor must be HER2- as defined by ASCO-CAP guidelines * Patients must have progressed on fulvestrant as a preceding treatment line (as first or second line therapy) * Previous treatment with a CDK4/6 inhibitor in the advanced setting * The presence of an activating PIK3CA mutation * Evaluable disease\* as defined per RECIST v.1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 Exclusion Criteria: * Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in theshort term * Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningealdisease as indicated by clinical symptoms, cerebral edema, and/or progressive growth * Prior treatment with a PI3K /AKT/mTOR inhibitor * Type 1 diabetes or uncontrolled type 2 diabetes (Hba1C \> 68 mmol/mol) * Clinically significant, uncontrolled heart disease and/or recent cardiac events

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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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