Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWenjin Yin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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-
Disqualifiers
during pregnancy and lactation
Patients with central nervous system metastasis
Trial design
Design model
Parallel
Treatments tested in this trial
XC
DrugCapecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
TPC
DrugAny physician's choice as maintenance therapy (except for XC regimen)
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: capecitabine and cyclophosphamide (XC)Experimental treatment 1 intervention
Group B: physician's choiceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 outcomes
1
Adverse events
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)]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wenjin Yin
Lead sponsor
RenJi Hospital
Sponsor institution
Source ClinicalTrials.gov