NCT05911958 is a Phase 2 clinical trial of SHR-A1811 for injection in HER2 Low Breast Carcinoma, sponsored by Henan Cancer Hospital.

Who is sponsoring NCT05911958?

NCT05911958 is sponsored by Henan Cancer Hospital.

What drugs are being tested in NCT05911958?

Interventions in NCT05911958: SHR-A1811 for injection.

What condition does NCT05911958 study?

NCT05911958 studies HER2 Low Breast Carcinoma.

Is NCT05911958 still recruiting?

NCT05911958 is currently recruiting now. Last updated 4 November 2024.

Last reviewed 2024-11-04 · How we verify

NCT05911958

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

A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

Recruiting now Phase 2 Last updated 4 November 2024

What this trial tests

Phase 2 trial testing SHR-A1811 for injection in HER2 Low Breast Carcinoma in 66 participants. Currently enrolling.

Timeline

5 July 2023

Primary endpoint
31 December 2024

31 May 2029

Quick facts

Lead sponsor	Henan Cancer Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	5 July 2023
Primary completion	31 December 2024
Estimated completion	31 May 2029
Sites	1 location across China

Drugs / interventions tested

SHR-A1811 for injection — full drug profile →

Conditions studied

HER2 Low Breast Carcinoma — all drugs for HER2 Low Breast Carcinoma →

Sponsor

Henan Cancer Hospital

Who can join

Adults 18 to 70, female only, with HER2 Low Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.

Publications & conference data

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

Management of patients with advanced-stage HER2-positive breast cancer: current evidence and future perspectives.
Marra A, Chandarlapaty S, Modi S. · · 2024 · cited 79× · PMID 38191924 · DOI 10.1038/s41571-023-00849-9
HER2-Low Breast Cancer: Now and in the Future.
Kang S, Kim SB. · · 2024 · cited 15× · PMID 38291745 · DOI 10.4143/crt.2023.1138
Antibody drug conjugates in the clinic.
Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
Novel treatment approaches utilizing antibody-drug conjugates in breast cancer.
Davis AA, Hesse J, Pereira PMR, Ma CX. · · 2025 · cited 8× · PMID 40360516 · DOI 10.1038/s41523-025-00743-w
Navigating antibody‒drug conjugates (ADCs): from metastatic to early breast cancer treatment strategies.
Najdi T, Awad L, Chartouni A, Soueidy C, et al · · 2025 · cited 5× · PMID 40304863 · DOI 10.1007/s10637-025-01525-8
Use of Antibody-Drug Conjugates in the Early Setting of Breast Cancer.
Koukoutzeli C, Trapani D, Ascione L, Kotteas E, et al · · 2024 · cited 5× · PMID 38894701 · DOI 10.1177/11795549241260418
Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention.
Lei H, Fu J, Gu W, Qiao H, et al · · 2026 · PMID 41510186 · DOI 10.1002/mco2.70560

Verify or expand the search:

Other recruiting trials for HER2 Low Breast Carcinoma

Currently open trials in the same condition.

NCT07198724 — ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrin · Phase 1, PHASE2 · recruiting
NCT06144944 — Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer · Phase 3 · active not recruiting
NCT05868226 — PRE-I-SPY Phase I/Ib Oncology Platform Program · Phase 1 · recruiting

Other Henan Cancer Hospital trials

Trials by the same sponsor.

NCT07442890 — A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Ro · NA · not yet recruiting
NCT07472621 — Real-World Effectiveness and Safety of Glofitamab in Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma · not yet recruiting
NCT07459608 — Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma · Phase 2 · not yet recruiting
NCT07400575 — Anlotinib in Cross-line Treatment of NSCLC and SCLC · not yet recruiting
NCT07332221 — Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial · Phase 3 · 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 NCT05911958 (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 Henan Cancer Hospital
Last refreshed: 4 November 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/NCT05911958.

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