RecruitingNot ApplicableNCT05876065

Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer

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

Sponsor

Wenjin Yin

Enrollment

86 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria2

during pregnancy and lactation
Patients with central nervous system metastasis

Interventions

DRUGXC

Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days

DRUGTPC

Any physician's choice as maintenance therapy (except for XC regimen)

Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

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NCT05876065

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