Metabolomics Explores Biomarkers for Metastatic Breast Cancer

• Conditions: Breast Cancer
• Interventions: Drug: There is no other intervention, only clinical treatment.

• Registration Number: NCT04302415
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-03
• Primary Completion: 2020-03-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
only liver metastasis	There is no other intervention, only clinical treatment.	There is no other intervention, only clinical treatment.
only lung metastasis	There is no other intervention, only clinical treatment.	There is no other intervention, only clinical treatment.
No distant metastasis	There is no other intervention, only clinical treatment.	There is no other intervention, only clinical treatment.

Primary Outcome Measures

Name	Time	Method
Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).	up to six months	To assess the changes of metabolites during the process of our observation, and to find out the relationship between metabolite(s) and therapeutic effect.

Secondary Outcome Measures

Name	Time	Method
progression of disease	Up to 10 years	To observe the duration from the stable condition to progression of disease. Patients were followed up every six months in first five years, then followed up once a year.
overall survival	Up to 10 years	To observe the duration from the stable condition to death. Patients were followed up every six months in first five years, then followed up once a year.

Trial Locations

Locations (1)

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China