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

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

Plain Language Summary

Simplified for easier understanding

This study looks at whether a two-drug oral combination — capecitabine (a chemotherapy tablet) and cyclophosphamide — can be used as maintenance therapy to keep advanced or metastatic breast cancer under control after a prior treatment has already stabilized the disease. Maintenance therapy aims to prolong the period of disease control without the need for more aggressive treatment. **You may be eligible if...** - You are a woman aged 18 or older - You have confirmed metastatic or recurrent breast cancer (including HER2-positive or triple-negative subtypes) - Your cancer responded to or was stabilized (partial response, complete response, or stable disease) by a prior treatment - You have at least one measurable tumor or bone-only disease on scans - Your overall health is good enough for treatment (ECOG 0–2) - Your organ function (blood, liver, kidneys) is adequate for chemotherapy - Your expected survival is at least 6 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cancer has spread to the brain (central nervous system metastases) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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