Back to resultsCapecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
Primary Purpose
Advanced Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
XC
TPC
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
capecitabine and cyclophosphamide (XC)
physician's choice
Arm Description
capecitabine and cyclophosphamide as maintenance therapy every 3 weeks
Any physician's choice as maintenance therapy (except for XC regimen).
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
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.
Secondary Outcome Measures
Adverse events
Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05876065
Brief Title
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenjin Yin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
capecitabine and cyclophosphamide (XC)
Arm Type
Experimental
Arm Description
capecitabine and cyclophosphamide as maintenance therapy every 3 weeks
Arm Title
physician's choice
Arm Type
Active Comparator
Arm Description
Any physician's choice as maintenance therapy (except for XC regimen).
Intervention Type
Drug
Intervention Name(s)
XC
Intervention Description
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
Intervention Type
Drug
Intervention Name(s)
TPC
Intervention Description
Any physician's choice as maintenance therapy (except for XC regimen)
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
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 Measure Information:
Title
Adverse events
Description
Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Time Frame
From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjin Yin, M.D.
Phone
86(21)68385569
Email
yinwenjin@renji.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjin Yin, M.D.
Organizational Affiliation
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
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