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

NCT06711094 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • HR+/HER2- Advanced Breast Cancer

Interventions

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

Sponsors & Collaborators

  • Fujian Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-12-30
Completion
2028-12-30

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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 NCT06711094 on ClinicalTrials.gov