NCT05154396 is a Phase 2 clinical trial of Neratinib in HER2-positive Breast Cancer, sponsored by Chinese Academy of Medical Sciences.

Who is sponsoring NCT05154396?

NCT05154396 is sponsored by Chinese Academy of Medical Sciences.

What drugs are being tested in NCT05154396?

Interventions in NCT05154396: Neratinib.

What condition does NCT05154396 study?

NCT05154396 studies HER2-positive Breast Cancer.

Is NCT05154396 still recruiting?

NCT05154396 is currently status unknown. Last updated 13 December 2021.

Last reviewed 2021-12-13 · How we verify

NCT05154396

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

Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Status unknown Phase 2 Last updated 13 December 2021

What this trial tests

Phase 2 trial testing Neratinib in HER2-positive Breast Cancer in 60 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Chinese Academy of Medical Sciences
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 January 2022
Primary completion	31 December 2023
Estimated completion	31 December 2024

Drugs / interventions tested

Neratinib — full drug profile →

Conditions studied

HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

Adults 18 to 75, female only, with HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective study on the prevention of Neratinib-related diarrhea in a Chinese population, exploring the best options for reducing the incidence of neratinib-related diarrhea through either pharmacologic intervention (prophylactic antidiarrheal therapy) or non-pharmacologic intervention (dose escalation program).

Publications & conference data

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

Beyond HER2: Targeting the ErbB receptor family in breast cancer.
Drago JZ, Ferraro E, Abuhadra N, Modi S. · · 2022 · cited 39× · PMID 35870237 · DOI 10.1016/j.ctrv.2022.102436
Neratinib for HER2-positive breast cancer with an overlooked option.
Guo L, Shao W, Zhou C, Yang H, et al · · 2023 · cited 33× · PMID 37803271 · DOI 10.1186/s10020-023-00736-0

Verify or expand the search:

Other trials of Neratinib

Trials testing the same drug.

NCT06813079 — Using Tumor Models to Determine Treatments · Phase 2 · not yet recruiting
NCT05919108 — Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers · Phase 2 · recruiting
NCT05491057 — Treatment Patterns of Neratinib in HER2+ EBC in China · not yet recruiting
NCT05243641 — Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients W · Phase 1, PHASE2 · terminated
NCT04886531 — Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers · Phase 2 · recruiting

Other recruiting trials for HER2-positive Breast Cancer

Currently open trials in the same condition.

NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer · Phase 3 · recruiting
NCT07510802 — Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC · Phase 1, PHASE2 · recruiting
NCT07486089 — Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) · Phase 1, PHASE2 · recruiting
NCT07102381 — A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Ca · Phase 2 · recruiting

Other Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

NCT05522894 — AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC · Phase 2 · unknown
NCT05499715 — A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy · Phase 1 · unknown
NCT05484024 — Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer · Phase 2, PHASE3 · not yet recruiting
NCT05543070 — Low-dose Radiotherapy in iNHL · Phase 2 · unknown
NCT05460403 — Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection · unknown

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 NCT05154396 (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 Chinese Academy of Medical Sciences
Last refreshed: 13 December 2021

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/NCT05154396.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing