Using capecitabine to reduce breast cancer recurrence in high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.