Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XC, TPC.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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 outcome measures
- Progression-Free Survival (PFS) [Time frame: 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)]
Secondary outcome measures (1)
- Adverse events [Time frame: From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai
Identifiers
NCT: NCT05876065 · LY2023-073-A