NCT06711094

Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC

Single-arm,Exploratory Clinical Study of Albumin-bound Paclitaxel Combination With Dalpiciclib and AI in the Treatment of ER-Low (1%-10%), HER2-negative Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.

Detailed description

This is a prospective, single-arm, single-center, open, exploratory clinical study. Simon two-stage sample size calculation was used in this study, and the primary endpoint was objective response rate (ORR). P0=37.3% (POLAMA-4 experimental group data), P1=53.2%, unilateral α=0.05, 1-β=80% were set. PASS15 software was used to calculate 21 cases in the first stage, with a total sample size of 52 cases. If 8 patients in Phase I achieve an objective response, proceed to Phase II. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative (IHC 0/1+ or IHC 2+ but ISH-) breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.

Conditions

• HR+/HER2- Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Dalpiciclib	Dalpiciclib: 125mg orally, with a treatment cycle every 28 days, with continuous administration for the first 3 weeks (days 1 to 21) and rest (no medication) for the second 1 week (days 22 to 28). It is recommended to take Dalpiciclib at about the same time every day. Albumin-bound paclitaxel for injection: 125mg/m2, intravenous infusion for 30 minutes, D1, D8, every 28 days for a treatment cycle, at least ≥6 treatment courses. Endocrine therapy: Endocrine therapy drugs are selected by the investigator

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2024-12-02
• Last updated: 2024-12-02