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

Sponsor
Wenjin Yin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05876065
Collaborator
(none)
86
Enrollment
2
Arms
45.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wenjin Yin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wenjin Yin, Deputy Chief of Breast Surgery Department, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05876065
Other Study ID Numbers:
  • LY2023-073-A
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of May 25, 2023