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

Wenjin Yin

Status: Enrolling

Conditions: Advanced Breast Cancer

Treatments: Drug: TPC; Drug: XC

Study type: Interventional

Funder types: Other

Identifiers

NCT05876065

LY2023-073-A

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

capecitabine and cyclophosphamide (XC)

Experimental group

Description:

capecitabine and cyclophosphamide as maintenance therapy every 3 weeks

Treatment:

Drug: XC

physician's choice

Active Comparator group

Description:

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

Treatment:

Drug: TPC