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

NCT ID: NCT05876065

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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capecitabine and cyclophosphamide (XC)

capecitabine and cyclophosphamide as maintenance therapy every 3 weeks

Group Type EXPERIMENTAL

XC

Intervention Type DRUG

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

physician's choice

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

Group Type ACTIVE_COMPARATOR

TPC

Intervention Type DRUG

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

Interventions

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XC

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

Intervention Type DRUG

TPC

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wenjin Yin

OTHER

Sponsor Role lead

Responsible Party

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Wenjin Yin

Deputy Chief of Breast Surgery Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenjin Yin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital,School of Medicine, Shanghai Jiaotong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjin Yin, M.D.

Role: CONTACT

86(21)68385569

Facility Contacts

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Wenjin Yin

Role: primary

86(21)68385569

Other Identifiers

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LY2023-073-A

Identifier Type: -

Identifier Source: org_study_id

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