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Neoplasm, BreastPhase 2SEQUEL-BreastNCT05392608

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

A Phase 2 study testing Alpelisib 150 MG Oral Tablet [Piqray] and Fulvestrant in people with Neoplasm, Breast and Congenital, Familial and Genetic Disorders, run by Borstkanker Onderzoek Groep at 25 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or second line, with or without previous use of CDK4/6-inhibitor) in patients with HR+ HER2… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Alpelisib 150 MG Oral Tablet [Piqray] and Fulvestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
25 sitesNetherlands
Study dates
2 Jun 2022to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Netherlands25 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Noordwest Ziekenhuisgroep

    Alkmaar

  • Ziekenhuisgroep Twente

    Almelo

  • Meander Medisch Centrum

    Amersfoort

  • Ziekenhuis Amstelland

    Amstelveen

  • Amsterdam UMC

    Amsterdam

  • Antoni van Leeuwenhoek

    Amsterdam

  • Gelre Ziekenhuizen

    Apeldoorn

  • Rijnstate

    Arnhem

  • Amphia

    Breda

  • Reinier de Graaf Gasthuis

    Delft

  • Deventer ziekenhuis

    Deventer

  • Máxima Medisch Centrum

    Eindhoven

  • Medisch Spectrum Twente

    Enschede

  • Admiraal de Ruyter Ziekenhuis

    Goes

  • Martini Ziekenhuis

    Groningen

  • Spaarne Gasthuis

    Hoofddorp

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

  • Maasstad Ziekenhuis

    Rotterdam

  • Franciscus Gasthuis & Vlietland

    Schiedam

  • HagaZiekenhuis

    The Hague

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg

  • VieCuri Medisch Centrum

    Venlo

Other trials in Netherlands

About this study

Official title: SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast): A Phase 2 Study on Fulvestrant Beyond Progression in Combination With Alpelisib for PIK3CA-mutated, Hormone-receptor Positive HER2 Negative Advanced Breast Cancer

The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or second line, with or without previous use of CDK4/6-inhibitor) in patients with HR+ HER2- advanced breast cancer with PIK3CA mutated tumors.

All eligible patients must have progressive disease on fulvestrant as latest treatment line.

Read more

Previous treatment with a CDK4/6 inhibitor in first or second line is obligatory. After progressive disease is confirmed, it is important to continue fulvestrant (without CDK4/6 inhibition) during the screening period awaiting study enrollment.

After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression. Follow-up time will be until progression or death or until a different oncolytic treatment has started (in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented).

Should participants discontinue due to reasons other than progression or death (e.g. toxicity), then they should still be evaluated for disease progression every 8 weeks as per protocol until progression, unless they do not wish to proceed with these screenings, or receive a different oncolytic treatment.

Being tested
Alpelisib 150 MG Oral Tablet [Piqray], Fulvestrant
Keywords
Hormone receptor positive HER2 negative breast cancer, PIK3CA-activated mutation
Medical subject headings
Breast Neoplasms, Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alpelisib 150 MG Oral Tablet [Piqray]Drug

    Also called Piqray

    Alpelisib 300mg once daily (may be reduced to 1dd250 or 1dd200mg in case of toxicity)

  • FulvestrantDrug

    Also called Faslodex

    Fulvestrant 300mg 1x/four weeks

Study groups in NCT05392608
Study groupRoleWhat they receive
Arm A (one-arm study)ExperimentalAlpelisib plus fulvestrant beyond progression
Receives: Drug: Alpelisib 150 MG Oral Tablet [Piqray]; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped and another treatment is initiated without confirmed disease progression.

    Measured: From registration to progression, assessed up to 36 months

Secondary outcomes (4)

  1. 'On treatment' Progression-free survival (PFS)

    Defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped earlier than disease progression

    Measured: From registration to progression, assessed up to 36 months

  2. Objective Response Rate

    Described as complete response (CR) or partial response (PR)

    Measured: From registration to progression, assessed up to 36 months

  3. Clinical Benefit Rate

    Described as stable disease (SD), PR, or CR

    Measured: From registration to progression, assessed up to 36 months

  4. Duration of Response (DoR)

    Duration of Response

    Measured: From registration to progression, assessed up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start2 Jun 2022
  3. Primary completion7 May 2026
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392608
Sponsor's protocol ID
BOOG 2021-01 SEQUEL-Breast
Acronym
SEQUEL-Breast
Status last verified
May 2026
First submitted
16 May 2022
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alpelisib 150 MG Oral Tablet [Piqray] and Fulvestrant in people with Neoplasm, Breast and Congenital, Familial and Genetic Disorders, run by Borstkanker Onderzoek Groep at 25 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From registration to progression, assessed up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05392608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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