Tailoring NEOadjuvant Therapy in Hormone Receptor Positive HER2 Negative Luminal Breast Cancer.

  • STATUS
    Recruiting
  • End date
    Aug 23, 2025
  • participants needed
    100
  • sponsor
    Borstkanker Onderzoek Groep
Updated on 28 July 2021
luminal
paclitaxel
cancer
cyclophosphamide
measurable disease
breast cancer
doxorubicin
HER2
docetaxel
erbb2
letrozole
immunostimulant
mammogram
core needle biopsy
ki-67
renal function test

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.

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%).

Details
Condition Breast Cancer, breast tumors, tumor of the breast, breast tumor
Treatment Letrozole, Chemotherapy, Ribociclib plus letrozole
Clinical Study IdentifierNCT03283384
SponsorBorstkanker Onderzoek Groep
Last Modified on28 July 2021

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