MedTrace Logo

Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer

NCT07285382 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-16

No results posted yet for this study

Summary

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.

Conditions

  • HR Positive HER2 Negative Advanced Breast Cancer

Interventions

DRUG

Dalpiciclib 125mg

Oral administration, 125mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest

DRUG

Dalpiciclib 150mg

Oral administration, 150mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest

DRUG

Letrozole 2.5mg

Oral administration, 2.5mg, administered once daily until disease progression or unacceptable toxicity

Sponsors & Collaborators

  • wanghaibo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07285382 on ClinicalTrials.gov