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NCT Number: NCT05876065

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

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XC

Drug

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

TPC

Drug

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Wenjin Yin

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 25, 2023
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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