Last updated on January 2019

Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone Receptor Positive Advanced Breast Cancer

Brief description of study

Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is superior to the sequence of an aromatase inhibitor in first line followed by fulvestrant plus CDK4/6 in second line.

Detailed Study Description

Combining cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors with endocrine therapies in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer has shown to result in substantial improvements in progression-free survival. There is however no evidence that this combination strategy leads to an improved overall survival. Furthermore, no specific subgroups that will or will not benefit from the combination of drugs have been identified yet. This means the optimal strategy for deploying CDK 4/6 inhibitors in clinical practice is not yet known. Since CDK 4/6 inhibitors are costly and can have toxic effects, it is important to determine the optimal treatment strategy to avoid both over- and undertreatment.

The SONIA-trial is an investigator-initiated, multicenter, randomized phase III study. The primary objective of this study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK 4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free survival compared to treatment with a non-steroidal aromatase inhibitor in first line followed at progression by fulvestrant combined with CDK4/6 inhibition in second line (strategy B). The primary end point is progression-free survival after two lines (PFS2), secondary end points include overall survival, quality of life, safety and biomarker analyses.

Clinical Study Identifier: NCT03425838

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G Sonke

Nki - Avl
Amsterdam, Netherlands
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I Konings

Amsterdam, Netherlands
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A Jager

Erasmus MC
Rotterdam, Netherlands
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S. Vrijaldenhoven

Alkmaar, Netherlands
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E.J.M. Siemerink

Almelo, Netherlands
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D.W. Sommeijer

Almere, Netherlands
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H.J. Bloemendal

Meander Medisch Centrum
Amersfoort, Netherlands
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A.A. Van Zweeden

Ziekenhuis Amstelland
Amstelveen, Netherlands
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S.E. Dohmen

BovenIJ Ziekenhuis
Amsterdam, Netherlands
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S.C.S. Tromp

Gelre ziekenhuizen
Apeldoorn, Netherlands
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R.J.B. Blaisse

Arnhem, Netherlands
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P. Nieboer

Wilhelmina ziekenhuis
Assen, Netherlands
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A.N.M. Goossens

Rode Kruis Ziekenhuis
Beverwijk, Netherlands
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E. Goker

Alexander Monro Ziekenhuis
Bilthoven, Netherlands
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Y.J.L. Kamm

Maasziekenhuis Pantein
Boxmeer, Netherlands
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J.B. Heijns

Breda, Netherlands
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K.J. Beelen

Reinier de Graaf
Delft, Netherlands
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J. Tol

Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
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H.M. Oosterkamp

Haaglanden Medisch Centrum
Den Haag, Netherlands
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D. Houtsma

Den Haag, Netherlands
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A.L.T. Imholz

Deventer Ziekenhuis
Deventer, Netherlands
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A. Dietvorst

Van Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
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E.W. Muller

Slingeland Ziekenhuis
Doetinchem, Netherlands
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S. Hovenga

Nij Smellinghe
Drachten, Netherlands
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A.W. Haringhuizen

Gelderse Vallei
Ede, Netherlands
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B.E.P.J. Vriens

Catharina Ziekenhuis
Eindhoven, Netherlands
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M.W. Dercksen

Maxima Medisch Centrum
Eindhoven, Netherlands
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J.J. Jansen

Treant Zorggroep
Emmen, Netherlands
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A. Smals

St. Anna Ziekenhuis
Geldrop, Netherlands
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E.C.J. Janssens - van Vliet

Admiraal de Ruyter
Goes, Netherlands
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M.M.J.A. Van Bokhoven

Rivas Beatrixziekenhuis
Gorinchem, Netherlands
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J.W.E. Hokken

Groene Hart Ziekenhuis
Gouda, Netherlands
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A.W.G. Van der Velden

Martini Ziekenhuis
Groningen, Netherlands
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C.P. Schroder

UMC Groningen
Groningen, Netherlands
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J.A. Ropela

Sint Jansdal
Harderwijk, Netherlands
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J. De Boer

Heerenveen, Netherlands
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M.J.A.E. Pepels

Elkerliek ziekenhuis
Helmond, Netherlands
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S.A. Luykx - de Bakker

Hilversum, Netherlands
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A. Beeker

Spaarne Gasthuis
Hoofddorp, Netherlands
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M Vleugel

Dijklander Ziekenhuis
Hoorn, Netherlands
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H. De Graaf

MC Leeuwarden
Leeuwarden, Netherlands
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J.R. Kroep

Leiden, Netherlands
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J.M. Bollen

MC Zuiderzee
Lelystad, Netherlands
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P.C. De Jong

St. Antonius
Nieuwegein, Netherlands
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C.M.P.W. Mandigers

Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
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H. Maters

Nijmegen, Netherlands
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K.N.A. Aaldering

Roermond, Netherlands
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M. Troost

Bravis ziekenhuis
Roosendaal, Netherlands
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Q.C. Van Rossum - Schornagel

Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
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F.E. De Jongh

Rotterdam, Netherlands
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A. Van der Padt - ...

Maasstad Ziekenhuis
Rotterdam, Netherlands
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F.L.G. Erdkamp

Sittard, Netherlands
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G.J. Veldhuis

Antonius Ziekenhuis
Sneek, Netherlands
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S. Mohkamsing

Spijkenisse Medisch Centrum
Spijkenisse, Netherlands
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M.A. Van Dijk

Terneuzen, Netherlands
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C.M.F. Kruijtzer - Schimmel

Ziekenhuis Rivierenland
Tiel, Netherlands
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J.M.G.H. Van Riel

Elisabeth Tweesteden
Tilburg, Netherlands
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A.H. Vos

Uden, Netherlands
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D. Ten Bokkel Huinink

Utrecht, Netherlands
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R.M.L. Bijlsma

UMC Utrecht
Utrecht, Netherlands
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A.J. Van de Wouw

Venlo, Netherlands
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P.J. Den Haan

St. Jans Gasthuis
Weert, Netherlands
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P.P.J.B.M. Schiphorst

Streekziekenhuis Koningin Beatrix
Winterswijk, Netherlands
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S. Bakker

Zaans Medisch Centrum
Zaandam, Netherlands
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A.J.M. Van der Pas

Zoetermeer, Netherlands
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Recruitment Status: Open

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