Using capecitabine and cyclophosphamide for advanced breast cancer maintenance therapy
Official title: Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial
Run by RenJi Hospital · NCT05876065 · Data updated 2026-11-12
This study is testing if a combination of two drugs, capecitabine and cyclophosphamide, can help women with advanced breast cancer stay stable after their previous treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 86 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | June 2027 |
| Study ends | February 2028 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT05876065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 and older with advanced breast cancer who have achieved disease control after previous treatments.
✕Probably not a fit
Patients with central nervous system metastasis or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the efficacy and safety of a combination of capecitabine and cyclophosphamide (XC) compared to the physician's choice of treatment as maintenance therapy for patients with advanced breast cancer who have achieved disease control after salvage treatment. The trial will involve female participants aged 18 and older with confirmed recurrent or metastatic breast cancer. Patients must have at least one measurable lesion and demonstrate adequate organ function to be eligible for the study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective maintenance therapy option for patients with advanced breast cancer.
How similar studies have gone: While there have been various studies on maintenance therapies for breast cancer, the specific combination of capecitabine and cyclophosphamide as maintenance therapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, age≥18 years old * ECOG≤2 * Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions * HR+/HER2+ or HR-/HER2+ or HR-/HER2- * At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1 * Disease control (complete response + partial response + stable disease) after salvage treatment * Expected survival ≥6 months * Adequate organ function Exclusion Criteria: * during pregnancy and lactation * Patients with central nervous system metastasis
Where it's running
-
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China Recruiting
Study contacts
- Principal investigator: Wenjin Yin, M.D. — Renji Hospital,School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjin Yin, M.D.
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.