Actively Recruiting
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-11-21
286
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
The First Affiliated Hospital of Bengbu Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and willing to follow study procedures
- Female aged 18 to 80 years, pre- or post-menopausal
- Confirmed early high-risk HR+, HER2- invasive breast cancer without recurrence or distant metastasis
- Completed radical surgery with tumor-free margins
- Tumor stage IIB or III; or stage IIA with specific risk factors (grade 2 or 3, Ki67 ≥ 20%, Oncotype DX score ≥ 26, or MammaPrint high risk)
- Surgery to enrollment period within 12 months
- ECOG performance score of 3 or less
- Able to swallow oral endocrine drugs
- Agree to provide tumor tissue and blood samples for biomarker analysis
- Completed (neo)adjuvant chemotherapy and standard radiotherapy if indicated
You will not qualify if you...
- Prior treatment with any CDK4/6 inhibitors
- Presence of metastatic disease including contralateral axillary lymph nodes
- Received endocrine therapy for breast cancer prevention
- Unwilling to participate in quality of life questionnaires or provide tissue samples at recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
C
Chao Ni
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here