Recruiting
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.
ClinicalTrials.gov IDNCT05876065
PhaseNA
Enrollment86
SponsorWenjin Yin
Age18 Years
SexFEMALE
Conditions studied
Advanced Breast Cancer
About this study
To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.
Interventions
- Drug: XC — Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
- Drug: TPC — Any physician's choice as maintenance therapy (except for XC regimen)
Primary outcomes
- Progression-Free Survival (PFS) (From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year))
Eligibility information
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
Study locations
- Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.