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

Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876065
• Other study ID #: LY2023-073-A
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 2027

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Wenjin Yin, M.D.
• Phone: 86(21)68385569
• Email: yinwenjin[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: February 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• XC
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
• TPC
Any physician's choice as maintenance therapy (except for XC regimen)

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Wenjin Yin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Adverse events	Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.	From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]