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

NCT05392608 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-05-22

No results posted yet for this study

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- advanced breast cancer with PIK3CA mutated tumors.

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

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.

Conditions

  • Neoplasm, Breast
  • Congenital, Familial and Genetic Disorders

Interventions

DRUG

Fulvestrant

Fulvestrant 300mg 1x/four weeks

DRUG

Alpelisib 150 MG Oral Tablet [Piqray]

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

Sponsors & Collaborators

  • Novartis Pharma B.V.

    collaborator UNKNOWN

  • BOOG Study Center

    collaborator OTHER

  • Borstkanker Onderzoek Groep

    lead NETWORK

Principal Investigators

  • Vincent V.O. Dezentjé, MD PhD · NKI-AvL

  • Inge I.R. Konings, MD PhD · Amsterdam UMC

  • Monique M.E.M.M. Bos, MD PhD · Erasmuc MC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2026-05-07
Completion
2028-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392608 on ClinicalTrials.gov