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Trial Title:
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
NCT ID:
NCT05876065
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XC
Description:
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
Arm group label:
capecitabine and cyclophosphamide (XC)
Intervention type:
Drug
Intervention name:
TPC
Description:
Any physician's choice as maintenance therapy (except for XC regimen)
Arm group label:
physician's choice
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjin Yin
Phone:
86(21)68385569
Email:
yinwenjin@renji.com
Start date:
June 1, 2023
Completion date:
February 2027
Lead sponsor:
Agency:
Wenjin Yin
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05876065
