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Life sciences · Journal article
Breast Cancer Research · November 5, 2026
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To evaluate the antitumor activity and safety of CDK2/4/6 inhibitor culmerciclib plus endocrine therapy as first-line treatment in patients with hormone receptor-positive (HR + ), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. In this single-arm, phase 2 trial, women with HR+/HER- advanced breast cancer with no prior systemic treatments in the metastatic setting received oral culmerciclib 180 mg/day plus an oral aromatase inhibitor (anastrozole 1 mg/day or letrozole 2.5 mg/day) at the investigator’s discretion. The primary endpoint was confirmed objective response rate (ORR) per RECIST v1.1. Secondary endpoints were progression-free survival (PFS), overall survival (OS), clinical benefit rate, disease control rate (DCR), duration of response (DoR), and safety. In total, 39 patients were enrolled and received culmerciclib plus letrozole (n = 21) or anastrozole (n = 18). In the full analysis set (n = 39), the confirmed ORR per RECIST v1.1 was 64.1% (29/39; 95% CI 47.18, 78.80). DCR was 89.7% (35/39; 95% CI 75.78, 97.13), clinical benefit rate was 82.1% (32/39; 95% CI 66.47, 92.46), and median DoR was 34.1 months (95% CI 16.36, not reached [NE]). With a median follow-up of 28.9 months, median PFS was 24.9 months (95% CI 13.83, NE) and the 24-month OS rate was 82.6% (95% CI 65.26, 91.78). Subgroup analyses showed numerically higher antitumor response in patients without visceral metastasis and in those who were premenopausal or perimenopausal, with ORRs of 88.9% (95%CI 65.29, 98.62) and 80.0% (95% CI 51.91, 95.67), respectively, and median PFS of not reached (95% CI 19.25, NE) and 35.9 months (95% CI 24.94, NE), respectively. The most common grade ≥ 3 treatment-related adverse events were hypertriglyceridemia (20.5%) and white blood cell count decreased (15.4%). The combination of culmerciclib and an aromatase inhibitor as first-line treatment showed promising antitumor activity and was tolerable in patients with HR+/HER2- advanced breast cancer. Further validation of our findings is needed. Clinical Trial Registration: This study was registered on May 12, 2026, at the Chinese Clinical Trial Registry (No. ChiCTR2600124423).