Who is sponsoring NCT05163106?

NCT05163106 is sponsored by University Hospital, Akershus.

What drugs are being tested in NCT05163106?

Interventions in NCT05163106: Letrozole 2.5mg oral tablet; Ribociclib 600mg oral tablet, Goserelin.

What condition does NCT05163106 study?

NCT05163106 studies Breast Cancer, HER2-negative Breast Cancer, ER-positive Breast Cancer, Locally Advanced Breast Cancer, Luminal A Breast Cancer, Luminal B Breast Cancer.

Is NCT05163106 still recruiting?

NCT05163106 is currently completed. Last updated 2 August 2024.

Last reviewed 2024-08-02 · How we verify

NCT05163106: NEOLETRIB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole

Completed Phase 2 Last updated 2 August 2024

What this trial tests

Phase 2 trial testing Letrozole 2.5mg oral tablet; Ribociclib 600mg oral tablet in Breast Cancer in 85 participants. Completed in 30 July 2024.

Timeline

1 December 2022

Primary endpoint
30 July 2024

30 July 2024

Quick facts

Lead sponsor	University Hospital, Akershus
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	85
Start date	1 December 2022
Primary completion	30 July 2024
Estimated completion	30 July 2024
Sites	1 location across Norway

Drugs / interventions tested

Letrozole 2.5mg oral tablet; Ribociclib 600mg oral tablet — full drug profile →
Goserelin (goserelin) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →
ER-positive Breast Cancer — all drugs for ER-positive Breast Cancer →
Locally Advanced Breast Cancer — all drugs for Locally Advanced Breast Cancer →

Sponsor

University Hospital, Akershus

Who can join

18 and older, female only, with Breast Cancer or HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with locally advanced (stage III) breast cancer (LABC) are characterized by a significantly worse prognosis compared to patients with primarily operable breast cancer. While neoadjuvant chemotherapy has been the first choice in this situation for several decades, recent evidence suggests that some patients may experience an extraordinary effect from neoadjuvant endocrine treatments involving aromatase inhibitors as monotherapy or in modern drug combinations.Selected LABC patients admitted for treatment will be offered combination therapy including letrozole and ribociclib. The overall goal of the project is to improve understanding of tumor responses and resistance in patients suffering from ER-positive/HER-2 negative locally advanced breast cancer, focusing on the role of the immune system including the gut microbiome.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Role of Gut Microbiota in Breast Cancer and Drug Resistance.
Viswanathan S, Parida S, Lingipilli BT, Krishnan R, et al · · 2023 · cited 38× · PMID 36986390 · DOI 10.3390/pathogens12030468
Role of HOXA9 in solid tumors: mechanistic insights and therapeutic potential.
Tang L, Peng L, Tan C, Liu H, et al · · 2022 · cited 19× · PMID 36376832 · DOI 10.1186/s12935-022-02767-9
Gut microbiota interact with breast cancer therapeutics to modulate efficacy.
Arnone AA, Ansley K, Heeke AL, Howard-McNatt M, et al · · 2025 · cited 9× · PMID 39820166 · DOI 10.1038/s44321-024-00185-0
Single-cell RNA sequencing: enhancing the predictive accuracy of tumor immunotherapy efficacy.
Zhou W, Huang Z, Wu Z, Tang M, et al · · 2025 · cited 3× · PMID 40857744 · DOI 10.1042/ebc20253017
The NEOLETRIB trial: neoadjuvant treatment with Letrozole and Ribociclib in ER-positive, HER2-negative breast cancer.
Fjermeros K, Ghannoum S, Geisler SB, Bhargava S, et al · · 2024 · cited 3× · PMID 39073142 · DOI 10.1080/14796694.2024.2377531
Microbiome-targeted nanoplatforms and engineering approaches in breast cancer therapy.
Sabeel Z, Yang Z. · · 2025 · cited 2× · PMID 41168838 · DOI 10.1186/s12943-025-02456-x
Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer.
Abbasi MS, Afzal MZ, Sarwar T, Gamlen-Steves HA. · · 2025 · cited 1× · PMID 40940886 · DOI 10.3390/cancers17172788
Case report: An ultrasound-based approach as an easy tool to evaluate hormone receptor-positive HER-2-negative breast cancer in advanced/metastatic settings: preliminary data of the Plus-ENDO study.
Montella L, Di Marino L, Marino MA, Riccio V, et al · · 2024 · PMID 38690171 · DOI 10.3389/fonc.2024.1295772

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

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NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other University Hospital, Akershus trials

Trials by the same sponsor.

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NCT06721754 — Diabetes Related Foot Ulcers with Negative Pressure Wound Therapy · NA · recruiting
NCT06731985 — The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes. · recruiting
NCT06576752 — Management of Patients with Heart Failure At Home After Hospital Discharge · NA · recruiting
NCT06032715 — Brief Intervention for Sleep Medication Misuse Among Elderly · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05163106 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Akershus
Last refreshed: 2 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05163106.

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