Clinical trial · Interventional
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)
Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Single-arm, Open-label Trial
NCT05640778CI-TRIAL-00073467unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Luminal B/HER2-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalpiciclib combined with aromatase inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- neoadjuvant endocrine therapy
- description
- CDK4/6 inhibitor combined with aromatase inhibitor
- interventionNames
- Drug: Dalpiciclib combined with aromatase inhibitors
Primary outcomes (1)
- measure
- Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment
- timeFrame
- 3 years
- description
- Assess ki67 level through biopsy samples of patients
Secondary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is ≥ 18 years-old at the time of consent to participate this trial * Famale stage I-III breast cancer patients * HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR\<20% * No prior anti-cancer treatment * ECOG 0-1 Exclusion Criteria: * Known to have other aggressive malignant tumor in the past 5 years. * Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology. * There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * Female patients during pregnancy or lactation. * The investigator determines that subjects are not appropriate to participate in the study due to other factors.
References
Publications (0)
Data not yet available
No reference posted for this study.