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 23 January 2021
Investigator
J R Kroep, MD
Primary Contact
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (0.0 mi away) Contact
+29 other location
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 on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER50%, PR any), HER2 negative, stage II/ III breast cancer
Measurable disease (breast and/or lymph nodes)
WHO 0-2
Adequate bone marrow function (within 4 weeks prior to registration): WBC3.0x109/l, neutrophils 1.5 x 109/l, platelets 100 x 109/l
Adequate liver function (within 4 weeks prior to registration): bilirubin 1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT 2.5 x UNL, Alkaline Phosphatase 5 x UNL
Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be 50 ml/min
Accessible for treatment and follow-up
Written informed consent
Inclusion criteria randomization specific
In order to be eligible to be randomized in this study, a subject must meet
all of the following criteria
Registration in the NEOLBC trial before 2 weeks biopsy
Use of letrozole
Outcome central Ki67 determination in two weeks biopsy available

Exclusion Criteria

Evidence of distant metastases (M1)
Previous invasive breast cancer
Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole 14 days (+ max. 4 days) prior to registration and who are still on letrozole
Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Peripheral neuropathy > grade 2, whatever the cause
Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or QTcF 450 msec
Known hypersensitivity reaction to any of the components of the treatment (peanuts, soy)
Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Currently receiving any of the following substances and cannot be discontinued 7 days prior to randomisation
Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelo's, star-fruit, pomegranate and Seville oranges
That have a known risk to prolong the QT interval or induce Torsades de Pointes
That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
Herbal preparations/medications, dietary supplements
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
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