Spots Global Cancer Trial Database for SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
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Trial Identification
Brief Title: SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
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
Study ID: NCT05392608
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Noordwest Ziekenhuisgroep, Alkmaar, , Netherlands
Ziekenhuisgroep Twente, Almelo, , Netherlands
Meander Medisch Centrum, Amersfoort, , Netherlands
Ziekenhuis Amstelland, Amstelveen, , Netherlands
Amsterdam UMC, Amsterdam, , Netherlands
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
Gelre Ziekenhuizen, Apeldoorn, , Netherlands
Rijnstate, Arnhem, , Netherlands
Amphia, Breda, , Netherlands
Reinier de Graaf Gasthuis, Delft, , Netherlands
Jeroen Bosch Ziekenhuis, Den Bosch, , Netherlands
HagaZiekenhuis, Den Haag, , Netherlands
Deventer ziekenhuis, Deventer, , Netherlands
Máxima Medisch Centrum, Eindhoven, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
Admiraal de Ruyter Ziekenhuis, Goes, , Netherlands
Martini Ziekenhuis, Groningen, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
St. Antonius Ziekenhuis, Nieuwegein, , Netherlands
Canisius Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Maasstad Ziekenhuis, Rotterdam, , Netherlands
Franciscus Gasthuis & Vlietland, Schiedam, , Netherlands
Elisabeth-TweeSteden Ziekenhuis, Tilburg, , Netherlands
VieCuri Medisch Centrum, Venlo, , Netherlands
Contact Details
Name: Vincent V.O. Dezentjé, MD PhD
Affiliation: NKI-AvL
Role: PRINCIPAL_INVESTIGATOR
Name: Inge I.R. Konings, MD PhD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
Name: Monique M.E.M.M. Bos, MD PhD
Affiliation: Erasmuc MC
Role: PRINCIPAL_INVESTIGATOR
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