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Recruiting Not applicable

Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer

NCT05876065 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Not applicable
Started
2023-06-01
Last updated
2026-08-19

Condition(s) studied

Advanced Breast Cancer

Investigational drug(s) / intervention(s)

XCTPC

XC: Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days

TPC: Any physician's choice as maintenance therapy (except for XC regimen)

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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)
    PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05876065 on ClinicalTrials.gov ↗ ← All trials in China