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

NCT06373744 | Completed DMC

• 1 other identifier: SYSU-022
• Study Type: observational
• Target: 597
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; metronomic chemotherapy; capecitabine

Outcome Measures

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

  Baseline up to approximately 20 months

Secondary Outcomes (3)

• Overall Survival

  Baseline until death (up to approximately 40 months)

• Objective Response Rate

  Baseline up to approximately 20 months

• Disease Control Rate

  Baseline up to approximately 20 months

Study Arms (1)

metronomic chemotherapy

Patients with advanced breast cancer who received metronomic chemotherapy.

Drug: cyclophosphamide , methotrexate , vinorelbine ,capecitabine

Interventions

cyclophosphamide , methotrexate , vinorelbine ,capecitabine DRUG

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

metronomic chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced breast cancer taking metronomic chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Shusen Wang

Guangzhou, Gangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shusen Wang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CN (1)