This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast cancer. A centralized randomization system (IWRS) will be used for randomization, and stratification will be performed based on the following factors during randomization: 1) Visceral metastasis (yes vs no); 2) Disease-free interval (previously untreated vs 12 \< DFI ≤ 24 vs DFI \> 24). Cohort A: Dalpiciclib 125mg + Letrozole 2.5mg Cohort B: Dalpiciclib 150mg + Letrozole 2.5mg Imaging assessment will be conducted in accordance with the RECIST 1.1 criteria, and tumor imaging evaluation will be performed by investigators from the participating centers. Patients receiving dalpiciclib will undergo a safety visit 28 days after the last dose, followed by survival follow-up until the patient's death or trial termination (whichever comes first). Pharmacokinetic assessment: Blood samples will be collected once before dosing on Cycle 1 Day 15 (C1D15), 4 hours after dosing on C1D15, before dosing on Cycle 2 Day 1 (C2D1), and before dosing on Cycle 4 Day 1 (C4D1) to explore the population pharmacokinetic characteristics of dalpiciclib and the factors affecting its pharmacokinetics. The first dosing time of the subjects, each blood collection time, the dalpiciclib dosing time within three days before blood collection, and the dalpiciclib dosing time on the day of C1D15 blood collection must be accurately recorded. If dalpiciclib is not administered within 14 days before the planned PK blood collection, no PK blood collection will be performed on the day of that visit. If possible, PK samples should be collected simultaneously with samples for other laboratory tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Oral administration, 125mg,Dalpiciclib is administered for 3 weeks, followed by 1 week of rest
Oral administration, 150mg,Dalpiciclib is administered for 3 weeks, followed by 1 week of rest
Oral administration, 2.5mg, administered once daily until disease progression or unacceptable toxicity
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGQingdao University Affiliated Hospital
Qingdao, Shandong, China
RECRUITINGProgression - Free Survival (PFS)
Progression - Free Survival (PFS) is registered as 'Primary' as the most clinically impactful endpoint; other outcomes (ORR, DoR) are secondary per platform requirements, though protocol does not hierarchy
Time frame: From date of randomization until the date of first documented disease progression or death from any cause (whichever comes first), assessed per RECIST 1.1 criteria up to 104 weeks
Duration of Response (DoR)
Time from first documentation of complete response (CR) or partial response (PR) to disease progression (per RECIST 1.1) or recurrence, assessed by investigators via imaging
Time frame: From the date of first documented complete response (CR) or partial response (PR) (per RECIST 1.1, assessed by investigators via imaging) until the date of first documented disease progression (per RECIST 1.1) or recurrence, assessed up to 104 weeks
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