Using capecitabine to reduce breast cancer recurrence in high-risk patients
Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients: a Multicenter, Single-arm Clinical Trial
This study is testing if the drug capecitabine can help reduce the chances of breast cancer coming back in women aged 18-70 who are at high risk after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hanzhou, Zhejiang) |
| Trial ID | NCT05212454 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of capecitabine as an adjuvant therapy for female patients aged 18-70 with hormone receptor-positive, HER2-negative breast cancer who are at high risk of recurrence after radical surgery. The study focuses on patients with specific high-risk factors, such as multiple positive lymph nodes or large tumor size. By administering capecitabine post-surgery, the trial aims to determine if this treatment can significantly lower the chances of cancer returning within the critical early years following surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-70 who have undergone radical surgery for HR-positive, HER2-negative breast cancer and meet specific high-risk criteria.
Not a fit: Patients with low-risk breast cancer or those who have received prior treatment for their current breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of breast cancer recurrence in high-risk patients.
How similar studies have performed: Previous studies have indicated that adjuvant capecitabine may benefit similar patient populations, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hanzhou, Zhejiang
- the Second Affiliated Hospital of Zhejiang Univercity School of Medicine — Hanzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Wei Tian, Doctor
- Email: denyiweit@zju.edu.cn
- Phone: +86 13777825246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.