Using capecitabine and cyclophosphamide for advanced breast cancer maintenance therapy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05876065 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with central nervous system metastasis or those who are pregnant or lactating may not benefit from this 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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- 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
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.