Status:
RECRUITING
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Breast Cancer
Chemotherapy Effect
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
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 ca...
Eligibility Criteria
Inclusion
- Female, age 18-70 years.
- Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells \>1%) and HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative).
- Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic grade 3 or ki67 ≥ 20%; or residual lesions despite neoadjuvant chemotherapy.
- No prior treatment for present breast cancer onset.
- ECOG physical status score 0 to 1
- Hematological examination before treatment should meet: white blood cell count (WBC) ≥ 4.0×10\^9/L, neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count (PLT) ≥ 100×10\^9/L; hemoglobin (Hb) ≥ 90g/L; AST (sGOT), ALT (sGPT) ≤ 1.5 times the normal value upper limit, creatinine ≤ 1.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value.
- No serious impairment of heart, liver, kidney and other important organ functions.
Exclusion
- Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
- Women during pregnancy and breastfeeding after pregnancy.
- Women with proven distant metastases of breast cancer.
- Patients with proven sensory or motor nerve disease.
- Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.
- Patients who need long-term anticoagulant drugs for cardiovascular or thrombotic diseases.
- History of other tumors.
- Allergic to the study drug or its excipients, etc.
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05212454
Start Date
March 15 2023
End Date
December 1 2029
Last Update
April 25 2023
Active Locations (1)
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1
the Second Affiliated Hospital of Zhejiang Univercity School of Medicine
Hanzhou, Zhejiang, China