Status:
UNKNOWN
Metabolomics Explores Biomarkers for Metastatic Breast Cancer
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Brief Summary
RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis. PURPOSE: This clinical t...
Detailed Description
Imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers ...
Eligibility Criteria
Inclusion
- Age: 18-70 yrs.
- Any menopausal status.
- Any hormone receptor status.
- Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
- Patients must have measurable disease, per RECIST criteria v1.1.21.
- Estimated life expectancy of ≥ 12 weeks.
- Ability to swallow oral medications.
- Participants must have adequate organ function as defined by:
- ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL.
- creatinine \< 1.5 x UNL (upper normal limit).
- Total bilirubin \< 1.5x UNL.
- ALT \& AST \< 2.5xUNL; alkaline phosphatase \< 2.5xUNL.
- Creatine phosphokinase (CPK) ≤ 2.5 x UNL.
- Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI.
Exclusion
- Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- History of other malignancies.
- No measureable lesion is present, as defined by RECIST 1.1.
- Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.
- Concurrent interventional studies.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04302415
Start Date
October 1 2019
End Date
February 1 2023
Last Update
March 10 2020
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China