Who is sponsoring NCT06404463?

NCT06404463 is sponsored by Fudan University.

What drugs are being tested in NCT06404463?

Interventions in NCT06404463: QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Albumin-bound paclitaxel, Doxorubicin, Cyclophosphamide, Epirubicin.

What condition does NCT06404463 study?

NCT06404463 studies Early Breast Cancer, Neoadjuvant Therapy, HR+HER2- Breast Cancer.

Is NCT06404463 still recruiting?

NCT06404463 is currently not yet recruiting. Last updated 8 May 2024.

Last reviewed 2024-05-08 · How we verify

NCT06404463: QUEEN-Neo

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

QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer

Not yet recruiting Phase 2 Last updated 8 May 2024

What this trial tests

Phase 2 trial testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in Early Breast Cancer in 76 participants. Not yet recruiting.

Timeline

6 May 2024

Primary endpoint
6 November 2025

6 November 2030

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	6 May 2024
Primary completion	6 November 2025
Estimated completion	6 November 2030

Drugs / interventions tested

QL1706 (bispecific antibody targeting PD-1 and CLTA-4) — full drug profile →
Albumin-bound paclitaxel — full drug profile →
Doxorubicin (doxorubicin) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Epirubicin (EPIRUBICIN) — full drug profile →

Conditions studied

Early Breast Cancer — all drugs for Early Breast Cancer →
Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →
HR+HER2- Breast Cancer — all drugs for HR+HER2- Breast Cancer →

Sponsor

Fudan University

Who can join

Adults 18 to 70, female only, with Early Breast Cancer or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- early breast cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6

Verify or expand the search:

Other trials of QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

Trials testing the same drug.

NCT07416058 — PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC · Phase 2 · not yet recruiting
NCT07178171 — A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC · Phase 1 · recruiting
NCT07141186 — QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1/PD-L1 Antibody Therapy · Phase 2 · not yet recruiting
NCT06939855 — QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma · Phase 2 · recruiting
NCT07070700 — Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Chol · Phase 2 · recruiting

Other recruiting trials for Early Breast Cancer

Currently open trials in the same condition.

NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07327021 — MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC · Phase 2 · recruiting
NCT06984250 — Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer · recruiting
NCT06650423 — Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer · recruiting
NCT05827081 — Phase IIIb Study of Ribociclib + ET in Early Breast Cancer · Phase 3 · recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · 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 NCT06404463 (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 Fudan University
Last refreshed: 8 May 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/NCT06404463.

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