Clinical trial · Interventional
Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
NCT05512780CI-TRIAL-00060497unknownPhase 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)
This is a single-arm, open-label, exploratory clinical study
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalpiciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dalpiciclib+ letrozole
- description
- Dalpiciclib combined with Letrozole,28 days as one cycle. 1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. 2. Letrozole: 2.5mg, p.o., once a day, continuous administration.
- interventionNames
- Drug: Dalpiciclib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 24 month
- description
- Objective response rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Postmenopausal women aged ≥18 years, the definition of postmenopausal: 1. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or 2. Age \<60, natural postmenopausal state (defined as the spontaneous cessation of regular menstruation for at least 12 consecutive months, without other pathological or physiological causes), E2 and FSH at the postmenopausal levels 2. All patients were estrogen receptor (ER) positive (\>10%), HER2 -negative invasive breast cancer regardless of PR expression level. Immunohistochemistry (IHC) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization (ISH) test (HER-2/CEP17 ratio \<2.0); 3. Treatment-naive patients with stage Ⅱ-Ⅲ tumors whose tumor staging meets the criteria of the 8th edition of the American Joint Committee on Cancer (AJCC) Staging; Exclusion Criteria: * 1\. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Concurrently receiving any other anti-tumor therapy that those specified in the protocol; 3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 4. Stage Ⅳ breast cancer;
References
Publications (1)
- DERIVEDZhang L, Liu Y, Yang C, Ma J, Li Y, Luo R, Han J, Wang X, Zhang Z, Ma L, Cai H, Kong X, Wang Z, Zhou X, Shi J, Zhang Y, Wang M, Wang J, Geng C. Clinical efficacy and therapy response prediction of neoadjuvant dalpiciclib plus letrozole in postmenopausal patients with HR+/HER2- stage II-III breast cancer (DARLING 01): a single-arm, open-label, exploratory study. Breast Cancer Res. 2025 Feb 13;27(1):21. doi: 10.1186/s13058-025-01976-0. PMID 39948624