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CompletedNCT06373744Updated Apr 18, 2024

Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients

An observational study in Breast Cancer, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
597
Ages
18 Years and older
Sex
Female
01

Study summary

The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:

How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • metronomic chemotherapy
  • capecitabine
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 597 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Advanced breast cancer taking metronomic chemotherapy

Inclusion criteria

  1. Females, >18 years old;
  2. Diagnosed with advanced breast cancer when using metronomic chemotherapy;
  3. At least one clinical evaluation, including physical examination and imaging, according to the instructions of the supervising physician during the use of metronomic chemotherapy. Examinations include ultrasound, computed tomography, and magnetic resonance imaging;
  4. Metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included;
  5. The clinical pathological information that needs to be collected is complete.

Exclusion criteria

Exclusion Criteria:

  1. Taking the drug for less than 2 weeks;
  2. losing follow-up after taking the therapy;
  3. The patient's breast cancer was still in the early stage when taking the therapy.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
597 participants (actual)
Patient registry
No

Groups and cohorts

  • metronomic chemotherapy

    Patients with advanced breast cancer who received metronomic chemotherapy.

    Drug: cyclophosphamide , methotrexate , vinorelbine ,capecitabine

Interventions

  • Drugcyclophosphamide , methotrexate , vinorelbine ,capecitabine

    The drugs used in metronomic chemotherapy are cyclophosphamide (CTX), methotrexate (M), vinorelbine (VNR), and capecitabine

06

What researchers measure

Primary outcomes

  1. Progression free survival

    Time from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression

    Time frame: Baseline up to approximately 20 months

Secondary outcomes

  1. Overall Survival

    Time from randomization to date of death due to any cause

    Time frame: Baseline until death (up to approximately 40 months)

  2. Objective Response Rate

    Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from randomization until disease progression or death due to any cause.

    Time frame: Baseline up to approximately 20 months

  3. Disease Control Rate

    Disease control is defined as complete response (CR), partial response (PR), or stable disease (SD) \>24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.

    Time frame: Baseline up to approximately 20 months

07

Study locations

1 site
  • Shusen Wang
    Guangzhou, Gangdong, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06373744
Lead sponsor
Sun Yat-sen University
Responsible party
wang shusen (Dr, Sun Yat-sen University) — Principal investigator
First posted
Apr 18, 2024
Start date
Jan 1, 2023
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024
Last update
Apr 18, 2024

Study contacts

Shusen Wang, MD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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