Clinical trial NCT04302415: Metabolomics Explores Biomarkers for Metastatic Breast Cancer
Official title: Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: metastatic breast cancer
metabolomics
biomarkers
Clinical study
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).
timeFrame: up to six months
Secondary outcomes:
measure: progression of disease
timeFrame: Up to 10 years
measure: overall survival
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: YU Zhiyong, PhD
role: STUDY_CHAIR
affiliation: Shandong Cancer Hospital and Institute
name: WANG Fukai, MM
role: PRINCIPAL_INVESTIGATOR
References: