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OpenTrials
Completed

NCT Number: NCT06373744

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shusen Wang

Guangzhou, Gangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cyclophosphamide , methotrexate , vinorelbine ,capecitabine

Drug

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

Primary outcomes

  1. 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

  1. Overall Survival

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

    Time from randomization to date of death due to any cause

  2. Objective Response Rate

    Time frame: Baseline up to approximately 20 months

    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.

  3. Disease Control Rate

    Time frame: Baseline up to approximately 20 months

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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