Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
NCT ID: NCT05876065
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
86 participants
INTERVENTIONAL
2023-06-01
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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capecitabine and cyclophosphamide (XC)
capecitabine and cyclophosphamide as maintenance therapy every 3 weeks
XC
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
physician's choice
Any physician's choice as maintenance therapy (except for XC regimen).
TPC
Any physician's choice as maintenance therapy (except for XC regimen)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with central nervous system metastasis
18 Years
FEMALE
No
Sponsors
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Wenjin Yin
OTHER
Responsible Party
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Wenjin Yin
Deputy Chief of Breast Surgery Department
Principal Investigators
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Wenjin Yin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LY2023-073-A
Identifier Type: -
Identifier Source: org_study_id
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