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

November 18, 2023 updated by: Wenjin Yin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: capecitabine and cyclophosphamide (XC)
capecitabine and cyclophosphamide as maintenance therapy every 3 weeks
Drug: XC
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
Active Comparator: physician's choice
Any physician's choice as maintenance therapy (except for XC regimen).
Drug: TPC
Any physician's choice as maintenance therapy (except for XC regimen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenjin Yin

Investigators

  • Principal Investigator: Wenjin Yin, M.D., Renji Hospital,School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 18, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2023-073-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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