Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06373744
Enrollment
597
Registered
2024-04-18
Start date
2023-01-01
Completion date
2024-01-01
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, metronomic chemotherapy, capecitabine

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.

Interventions

DRUGcyclophosphamide , methotrexate , vinorelbine ,capecitabine

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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression free survivalBaseline up to approximately 20 monthsTime from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression

Secondary

MeasureTime frameDescription
Overall SurvivalBaseline until death (up to approximately 40 months)Time from randomization to date of death due to any cause
Objective Response RateBaseline up to approximately 20 monthsObjective 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.
Disease Control RateBaseline up to approximately 20 monthsDisease 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026