NCT05212454 Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
| NCT ID | NCT05212454 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2023-03-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05212454 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05212454 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT05212454 currently recruiting?
Yes, NCT05212454 is actively recruiting participants. Contact the research team at denyiweit@zju.edu.cn for enrollment information.
Where is the NCT05212454 trial being conducted?
This trial is being conducted at Hanzhou, China.
Who is sponsoring the NCT05212454 clinical trial?
NCT05212454 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 400 participants.
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