Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku od 18 do 75 lat, która ukończyła menopnazę lub się do niej zbliża
- •Potwierdzony rak piersi dodatni na receptor hormonalny i ujemny na HER2, z przerzutami lub nawrotem guza, niezdatny do operacji lub radioterapii
- •Ocena ogólnego stanu zdrowia (ECOG) 0-1
- •Nie otrzymywała żadnego wcześniejszego leczenia chemicznego na przerzuty lub nawrót
- •Widoczne zmiany nowotworowe lub przerzuty do kości
- •Prawidłowe funkcje narządów i szpiku kostnego
- •Gotowość do stosowania antykoncepcji podczas badania i 3 miesiące po jego zakończeniu
- •Podpisana świadoma zgoda na uczestnictwo w badaniu
✗ Disqualifies
- •Historia HER2-dodatniego raka piersi
- •Rak piersi o charakterze zapalnym
- •Nawrót lub progresja choroby w ciągu 12 miesięcy po zakończeniu poprzedniego leczenia hormonalnego
- •Zaawansowana choroba z objawami zagrażającymi życiu lub licznymi przerzutami do narządów wewnętrznych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- December 16, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Qingdao University Affiliated Hospital
Qingdao, China
Trial contact
haibo Wang
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.