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Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.

NCT06133088 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-11-15

No results posted yet for this study

Summary

This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6 treatment failed.

Conditions

  • Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed

Interventions

DRUG

dalpiciclib; fluvestrant; compound gossypol acetate tablets

Darcilie: 150mg orally for three weeks and stop for one week. Fluvestrant: 500mg every four weeks. A further 500mg dose two weeks after the first dose. Compound gossyrol acetate tablet: 20mg daily.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-12-31
Completion
2025-08-31

Countries

  • China

Study Locations

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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 NCT06133088 on ClinicalTrials.gov