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RECRUITING
NCT06587789

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Official title: A Multi-center, Prospective and Observational Study of Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

286

Start Date

2024-01-01

Completion Date

2027-01-01

Last Updated

2024-11-21

Healthy Volunteers

No

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).

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China