NCT05861635 is a Phase 4 clinical trial of Disitamab Vedotin combined with Tislelizumab in Breast Cancer, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

What drugs are being tested in NCT05861635?

Interventions in NCT05861635: Disitamab Vedotin combined with Tislelizumab.

What condition does NCT05861635 study?

NCT05861635 studies Breast Cancer, Neoadjuvant Therapy.

Is NCT05861635 still recruiting?

NCT05861635 is currently status unknown. Last updated 17 May 2023.

Last reviewed 2023-05-17 · How we verify

NCT05861635

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

The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

Status unknown Phase 4 Last updated 17 May 2023

What this trial tests

Phase 4 trial testing Disitamab Vedotin combined with Tislelizumab in Breast Cancer in 42 participants. Status unknown.

Timeline

1 February 2023

Primary endpoint
1 February 2025

1 February 2026

Quick facts

Lead sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 February 2023
Primary completion	1 February 2025
Estimated completion	1 February 2026
Sites	1 location across China

Drugs / interventions tested

Disitamab Vedotin combined with Tislelizumab — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

Adults 18 to 75, any sex, with Breast Cancer or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression

Publications & conference data

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

HER2-Low Breast Cancer: Now and in the Future.
Kang S, Kim SB. · · 2024 · cited 15× · PMID 38291745 · DOI 10.4143/crt.2023.1138
Immunotherapy and its racial specificity for breast cancer treatment in Asia: a narrative review.
Xu RC, Zhang YW, Liu CC, Xu YY, et al · · 2025 · cited 3× · PMID 40443538 · DOI 10.1016/j.lanwpc.2024.101180

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials

Trials by the same sponsor.

NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · 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 NCT05861635 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Last refreshed: 17 May 2023

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/NCT05861635.

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