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This is a single-arm, open-label, exploratory clinical study
This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage â…¡-â…¢ HR+/HER2- breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalpiciclib+ letrozole | Experimental | Dalpiciclib combined with Letrozole,28 days as one cycle.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib | Drug | An exploratory study of a single-arm, open design All subjects enrolled will receive the following treatment: Dalpiciclib combined with Letrozole, 28 days as one cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 24 month |
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Inclusion Criteria:
1. Postmenopausal women aged ≥18 years, the definition of postmenopausal:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39948624 | Derived | Zhang 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. |
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| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |