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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06373744
• Other study ID #: SYSU-022
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shusen Wang	Guangzhou	Gangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Time from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression	Baseline up to approximately 20 months
Secondary	Overall Survival	Time from randomization to date of death due to any cause	Baseline until death (up to approximately 40 months)
Secondary	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.	Baseline up to approximately 20 months
Secondary	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.	Baseline up to approximately 20 months