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Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer

NCT06587789 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 286

Last updated 2024-11-21

No results posted yet for this study

Summary

The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. The main question it aims to answer is:

Whether it is effective and safe to use ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer? Participants will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy for three years. During the follow-up, their relevant clinical data will be recorded.

Conditions

Interventions

DRUG

Ribociclib

Participants will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy (according to standard clinical practice, TAM or AI, with or without OFS).

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Jinhua Central Hospital

    collaborator OTHER

  • Taizhou Hospital

    collaborator OTHER

  • Ningbo Medical Center Lihuili Hospital

    collaborator OTHER_GOV

  • The Affiliated People's Hospital of Ningbo University

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    collaborator OTHER

  • First People's Hospital of Hangzhou

    collaborator OTHER

  • Affiliated Zhoushan Hospital of Wenzhou Medical University

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-01
Completion
2027-01-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06587789 on ClinicalTrials.gov