NCT05760612 is a Phase 3 clinical trial of Trastuzumab and neratinib in Early-stage Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Who is sponsoring NCT05760612?

NCT05760612 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

What drugs are being tested in NCT05760612?

Interventions in NCT05760612: Trastuzumab and neratinib, Trastuzumab and Pertuzumab.

What condition does NCT05760612 study?

NCT05760612 studies Early-stage Breast Cancer, HER2-positive Breast Cancer, Adjuvant Treatment After Trastuzumab, RCB Classification 1-2, Neratini.

Is NCT05760612 still recruiting?

NCT05760612 is currently recruiting now. Last updated 25 September 2025.

Last reviewed 2025-09-25 · How we verify

NCT05760612

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

Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

Recruiting now Phase 3 Last updated 25 September 2025

What this trial tests

Phase 3 trial testing Trastuzumab and neratinib in Early-stage Breast Cancer in 300 participants. Currently enrolling.

Timeline

14 March 2023

Primary endpoint
16 February 2028

1 November 2028

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	14 March 2023
Primary completion	16 February 2028
Estimated completion	1 November 2028
Sites	1 location across China

Drugs / interventions tested

Trastuzumab and neratinib — full drug profile →
Trastuzumab and Pertuzumab (trastuzumab-and-pertuzumab) — full drug profile →

Conditions studied

Early-stage Breast Cancer — all drugs for Early-stage Breast Cancer →
HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Adjuvant Treatment After Trastuzumab — all drugs for Adjuvant Treatment After Trastuzumab →
RCB Classification 1-2 — all drugs for RCB Classification 1-2 →

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 70, female only, with Early-stage Breast Cancer or HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive/HER2-positive breast cancer and RCB 0/I following neoadjuvant trastuzumab and pertuzumab therapy.

Publications & conference data

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

HER2-targeted therapies in cancer: a systematic review.
Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1
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 recruiting trials for Early-stage Breast Cancer

Currently open trials in the same condition.

NCT06215469 — Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads) · NA · recruiting
NCT06144944 — Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer · Phase 3 · active not recruiting
NCT06001762 — TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer · Phase 2 · active not recruiting
NCT05957068 — Breast Cancer Exercise Intervention Study · NA · recruiting
NCT06035016 — Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer · recruiting

Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials

Trials by the same sponsor.

NCT07168083 — Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression · not yet recruiting
NCT07413497 — A Prospective Observational Clinical Study on Exploring the Value of Surgical Excision Combined With 32P Application in · not yet recruiting
NCT07461077 — Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer · NA · not yet recruiting
NCT07533526 — Effects of Instrument-Assisted Constant-Speed Injection Versus Manual Injection on Pain From Large-Volume Subcutaneous I · NA · not yet recruiting
NCT07408648 — A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological · Phase 2 · not yet 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 NCT05760612 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last refreshed: 25 September 2025

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/NCT05760612.

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