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Abstract PS3-07-02: An Exploratory Clinical Trial of CDK4/6 Inhibitor Dalpiciclib Combined with Aromatase Inhibitors as Neoadjuvant Therapy for Stage II-III HR-positive HER2-negative Breast Cancer

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The trial aims to assess the efficacy and safety of dalpiciclib combined with aromatase inhibitors in neoadjuvant therapy for HR+/HER2- breast cancer.
Single-arm, multicenter, open-label phase II trial
Enrolled 45 treatment-naive women with HR+ and HER2- breast cancer
Patients received dalpiciclib and various aromatase inhibitors, with some receiving ovarian suppression
Overall response rate (ORR) was 46.9% with partial response in 14/32 patients
No patients achieved pathological complete response (pCR)
Ki-67 levels decreased from 20% to 5%, indicating reduced tumor proliferation
Majority (70.8%) showed moderate pathological response (grade 3)
35.2% of patients experienced grade ≥3 adverse events, primarily neutropenia

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This phase II trial evaluates neoadjuvant therapy outcomes in women with HR+/HER2- breast cancer, suggesting new treatment strategies.

Yang et al. (2026) studied this question.

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