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Clinical Trials/NCT06373744
NCT06373744
Completed
Not Applicable

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

Sun Yat-sen University1 site in 1 country597 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
cyclophosphamide , methotrexate , vinorelbine ,capecitabine
Conditions
Breast Cancer
Sponsor
Sun Yat-sen University
Enrollment
597
Locations
1
Primary Endpoint
Progression free survival
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

wang shusen

Dr

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Females, \>18 years old;
  • Diagnosed with advanced breast cancer when using metronomic chemotherapy;
  • 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;
  • Metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included;
  • The clinical pathological information that needs to be collected is complete.

Exclusion Criteria

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

Arms & Interventions

metronomic chemotherapy

Patients with advanced breast cancer who received metronomic chemotherapy.

Intervention: cyclophosphamide , methotrexate , vinorelbine ,capecitabine

Outcomes

Primary Outcomes

Progression free survival

Time Frame: Baseline up to approximately 20 months

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

Secondary Outcomes

  • Overall Survival(Baseline until death (up to approximately 40 months))
  • Disease Control Rate(Baseline up to approximately 20 months)
  • Objective Response Rate(Baseline up to approximately 20 months)

Study Sites (1)

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