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

Not Applicable

Recruiting

• Conditions: Advanced Breast Cancer
• Interventions: Drug: XC; Drug: TPC

• Registration Number: NCT05876065
• Lead Sponsor: Wenjin Yin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Study Start: 2023-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
capecitabine and cyclophosphamide (XC)	XC	capecitabine and cyclophosphamide as maintenance therapy every 3 weeks
physician's choice	TPC	Any physician's choice as maintenance therapy (except for XC regimen).

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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)	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

Name	Time	Method
Adverse events	From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]	Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China