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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: cyclophosphamide , methotrexate , vinorelbine ,capecitabine

• Registration Number: NCT06373744
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 597

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metronomic chemotherapy	cyclophosphamide , methotrexate , vinorelbine ,capecitabine	Patients with advanced breast cancer who received metronomic chemotherapy.

Primary Outcome Measures

Name	Time	Method
Progression free survival	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 Outcome Measures

Name	Time	Method
Overall Survival	Baseline until death (up to approximately 40 months)	Time from randomization to date of death due to any cause
Disease Control Rate	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.
Objective Response Rate	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.

Trial Locations

Locations (1)

Shusen Wang; 🇨🇳 Guangzhou, Gangdong, China