Breast Cancer
Conditions
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
The drugs used in metronomic chemotherapy are cyclophosphamide (CTX), methotrexate (M), vinorelbine (VNR), and capecitabine
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Baseline until death (up to approximately 40 months) | Time from randomization to date of death due 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. |
| 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. |
Countries
China