Metabolomics Explores Biomarkers for Metastatic Breast Cancer

Shandong First Medical University

Status

Unknown

Conditions

Breast Cancer

Treatments

Drug: There is no other intervention, only clinical treatment.

Study type

Observational

Funder types

Other

Identifiers

NCT04302415

OMICS Mark

Details and patient eligibility

About

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 trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.

Full 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 that could reflect visceral metastasis and treatment effects. The purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis.

Patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. Analysis of metabolites in plasma using ultra high performance liquid chromatography. Patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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:
1. ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL.
2. creatinine < 1.5 x UNL (upper normal limit).
3. Total bilirubin < 1.5x UNL.
4. ALT & AST < 2.5xUNL; alkaline phosphatase < 2.5xUNL.
5. 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 criteria

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.