Spots Global Cancer Trial Database for Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
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Trial Identification
Brief Title: Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
Official Title: Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
Study ID: NCT03283384
Conditions
Study Description
Brief Summary: The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.
Detailed Description: Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 \<1%) or will be randomized between standard chemotherapy (AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, , Netherlands
Ziekenhuisgroep Twente, Almelo, , Netherlands
Ziekenhuis Amstelland, Amstelveen, , Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek, Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Gelre Ziekenhuizen, Apeldoorn, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Stichting Reinier Haga Groep (Reinier de Graaf Gasthuis), Delft, , Netherlands
Haaglanden Medisch Centrum, Den Haag, , Netherlands
HAGA Ziekenhuis, Den Haag, , Netherlands
Stichting Deventer Ziekenhuisgroep, Deventer, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
Groene Hart Ziekenhuis, Gouda, , Netherlands
Spaarne Gasthuis, Haarlem, , Netherlands
Ziekenhuis St. Jansdal, Harderwijk, , Netherlands
Tergooi Ziekenhuizen, Hilversum, , Netherlands
Westfriesgasthuis, Hoorn, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Laurentius Ziekenhuis, Roermond, , Netherlands
Bravis Ziekenhuis, Roosendaal, , Netherlands
Antonius Ziekenhuis, Sneek, , Netherlands
Ziekenhuis Rivierenland, Tiel, , Netherlands
Elisabeth Tweesteden Ziekenhuis, Tilburg, , Netherlands
VieCuri Medisch Centrum, Venlo, , Netherlands
Streekziekenhuis Koningin Beatrix, Winterswijk, , Netherlands
Isala, Zwolle, , Netherlands
Contact Details
Name: Judith R Kroep, MD PhD
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Sabine C Linn, Prof. MD
Affiliation: NKI-AvL
Role: PRINCIPAL_INVESTIGATOR
Name: Gerrit-Jan Liefers, MD PhD
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: A. E van Leeuwen-Stok, PhD
Affiliation: BOOG Study Center
Role: STUDY_DIRECTOR
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