Clinical trial · Interventional
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
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
NCT05876065CI-TRIAL-00122885recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TPC | Drug | — | UNRESOLVED |
| XC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- capecitabine and cyclophosphamide (XC)
- description
- capecitabine and cyclophosphamide as maintenance therapy every 3 weeks
- interventionNames
- Drug: XC
- type
- ACTIVE_COMPARATOR
- label
- physician's choice
- description
- Any physician's choice as maintenance therapy (except for XC regimen).
- interventionNames
- Drug: TPC
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 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
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.