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PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

NCT06612814 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2024-09-25

No results posted yet for this study

Summary

This study is a prospective, open-label, phase III clinical study for patients with HR+/HER2- advanced breast cancer.

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Fluzoparib

Parp inhibitor

DRUG

Dalpiciclib

CDK4/6 inhibitor

DRUG

Fulvestrant/AI

Endocrine therapy

Sponsors & Collaborators

  • First Hospital of China Medical University

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Chongqing University Cancer Hospital

    collaborator OTHER

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • Ningbo Medical Center Lihuili Hospital

    collaborator OTHER_GOV

  • Shanghai First Maternity and Infant Hospital

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Zhimin Shao

    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
2024-09-01
Primary Completion
2027-10-30
Completion
2028-04-30

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 NCT06612814 on ClinicalTrials.gov