The NEOLETRIB trial: neoadjuvant treatment with Letrozole and Ribociclib in ER-positive, HER2-negative breast cancer

Future Oncol. 2024;20(32):2457-2466. doi: 10.1080/14796694.2024.2377531. Epub 2024 Jul 29.

Abstract

Chemotherapy is used as neoadjuvant therapy for all subgroups of breast cancer, including ER-positive, and HER2-negative cases. However, studies have suggested that using aromatase inhibitors combined with CDK4/6-inhibitors might be an appropriate alternative in selected patients. Thus, the NEOLETRIB trial evaluates the response of ER-positive, HER2-negative luminal A/B breast cancer to the combination of letrozole and ribociclib in the neoadjuvant setting. Comprehensive molecular biology procedures, including sequential single-cell RNA-sequencing of tumor biopsies, are performed during 6 months of treatment with extensive biobanking of blood samples, tumor biopsies and gut microbiome specimens. Our findings will hopefully contribute to an improved selection of patients who may benefit from this drug combination and give new insights into the intra-tumoral changes during this treatment.Trial registration number: NCT05163106 (ClinicalTrials.gov).

Keywords: HR positive; gut microbiome; letrozole; locally advanced breast cancer; neoadjuvant; ribociclib; senescence; single-cell RNA sequencing.

Plain language summary

[Box: see text].

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aminopyridines* / administration & dosage
  • Aminopyridines* / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / pathology
  • Female
  • Humans
  • Letrozole* / administration & dosage
  • Letrozole* / therapeutic use
  • Middle Aged
  • Neoadjuvant Therapy* / methods
  • Purines* / administration & dosage
  • Purines* / therapeutic use
  • Receptor, ErbB-2* / metabolism
  • Receptors, Estrogen* / metabolism
  • Treatment Outcome

Substances

  • Aminopyridines
  • ERBB2 protein, human
  • Letrozole
  • Purines
  • Receptor, ErbB-2
  • Receptors, Estrogen
  • ribociclib

Associated data

  • ClinicalTrials.gov/NCT05163106