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NCT05640778

Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)

Status unknown Phase 2 Last updated 31 January 2024
What this trial tests

Phase 2 trial testing Dalpiciclib combined with aromatase inhibitors in Luminal B/HER2-negative Breast Cancer in 30 participants. Status unknown.

Timeline
1 October 2022
Primary endpoint
31 October 2024
31 October 2025

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 October 2022
Primary completion31 October 2024
Estimated completion31 October 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

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

Sponsor's own description

Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.

Publications & conference data

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

  1. Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
    Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234
  2. Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors.
    Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, et al · · 2026 · PMID 41943159 · DOI 10.1186/s13045-026-01794-7
  3. Efficacy, Safety, and Biomarkers of Neoadjuvant Dalpiciclib (CDK4/6 inhibitor) plus Aromatase Inhibitors in Operable HER2-Negative Luminal B Breast Cancer: A Prospective, Single-Center, Single-Arm, Phase II Trial (DANCER).
    Zhou Y, Zhang Z, Chen H, Huang F, et al · · 2025 · PMID 41079649 · DOI 10.1002/mco2.70402

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Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

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