NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant | Biotech Hunter

Enrollment

388

Participants

Timeline

Start Date

September 6, 2016

Primary Completion Date

February 15, 2023

Study Completion Date

February 15, 2023

Conditions

Breast CancerHormone Receptor Positive TumorHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast

Interventions

DRUG

Palbociclib

"Capsules (commercially available, obtained from local pharmacies), 125mg daily, 21 days, 7 days off, cycles of 28 days.~Dose reductions: 100mg, 75mg (no change in administration schedule) Number of cycles: until disease progression, intolerable toxicity, death or any other reasons"

DRUG

Letrozole

Letrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 2.5mg/daily, oral intake

DRUG

Anastrozole

Anastrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 1mg/daily, oral intake

DRUG

Exemestane

Exemestane will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 25mg/daily, oral intake

DRUG

Fulvestrant

Fulvestrant will be administered as basic therapy (commercially available injection, obtained from local pharmacies) as followed: 500mg/once monthly, intramuscular injection

Trial Locations (70)

Unknown

Research Site, Aachen

Research Site, Aschaffenburg

Augsburg

Research Site, Baden-Baden

Research Site, Berlin

Bochum

Bonn

Research Site, Bottrop

Bremerhaven

Research Site, Celle

Dessau

Research Site, Donauwörth

Research Site, Dortmund

Research Site, Dresden

Research Site, Essen

Research Site, Esslingen am Neckar

Research Site, Frankfurt

Research Site, Freiburg im Breisgau

Research Site, Gerlingen

Goslar

Research Site, Göttingen

Göttingen

Greifswald

Güstrow

Research Site, Gütersloh

Research Site, Halle

Research Site, Hamburg

Homburg

Ilsede

Kaiserslautern

Research Site, Karlsruhe

Research Site, Kassel

Research Site, Krefeld

Research Site, Langen

Research Site, Leer

Loerrach

Lübeck

Lüneburg

Mannheim

Minden

Research Site, Mönchengladbach

Research Site, Mühlhausen

Mülheim

Research Site, München

München

Research Site, Münster

Neumünster

Neuruppin

Offenburg

Oldenburg

Passau

Potsdam

Research Site, Recklinghausen

Research Site, Regensburg

Rostock

Saarbrücken

Schorndorf

Research Site, Singen

Speyer

Stade

Stolberg

Stuttgart

Traunstein

Research Site, Ulm

Villingen-Schwenningen

Westerstede

Research Site, Wilhelmshaven

Witten

Würselen

Würzburg