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

NCT05876065 | Recruiting

• 1 other identifier: LY2023-073-A
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]

Study Arms (2)

capecitabine and cyclophosphamide (XC)

EXPERIMENTAL

capecitabine and cyclophosphamide as maintenance therapy every 3 weeks

Drug: XC

physician's choice

ACTIVE COMPARATOR

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

Drug: TPC

Interventions

XC DRUG

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

capecitabine and cyclophosphamide (XC)

TPC DRUG

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

physician's choice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• during pregnancy and lactation
• Patients with central nervous system metastasis

Sponsors & Collaborators

• Wenjin Yin: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)