Actively Recruiting
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-04-25
400
Participants Needed
1
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases. Among Chinese breast cancer patients, approximately 60% are hormone receptor (HR) positive, and 80% have early-stage breast cancer. For HR-positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer patients, the first peak of recurrence is about 2-3 years after surgery, especially for patients with high-risk clinical and/or pathological features. Therefore, adjuvant therapy is essential to reduce recurrence during this period. Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil (5-Fu) in vivo. Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer. Therefore, we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors. This trial is an open, single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors.
CONDITIONS
Official Title
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18-70 years
- Completed radical breast cancer surgery with confirmed primary invasive breast adenocarcinoma that is ER and/or PR positive and HER2 negative
- High-risk factors defined as 4 or more positive axillary lymph nodes; or 1-3 positive axillary lymph nodes with tumor size 65 cm, histologic grade 3, or ki67 65 20%; or residual cancer after neoadjuvant chemotherapy
- No prior treatment for the current breast cancer
- ECOG physical status score of 0 or 1
- Blood tests meeting specific levels for white blood cells, neutrophils, platelets, hemoglobin, liver enzymes, creatinine, and bilirubin
- No serious impairment of heart, liver, kidney, or other important organ functions
You will not qualify if you...
- Unable or unwilling to use contraception during treatment and for 8 weeks after
- Pregnant or breastfeeding women
- Breast cancer with distant metastases
- Sensory or motor nerve diseases
- Serious cardiovascular disease, severe co-morbidities, active infections including HIV
- Need for long-term anticoagulant therapy for heart or clotting disorders
- History of other cancers
- Allergy to capecitabine or its ingredients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital of Zhejiang Univercity School of Medicine
Hanzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Wei Tian, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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