Metabolomics Explores Biomarkers for Metastatic Breast Cancer

Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: There is no other intervention, only clinical 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Fukai WANG, MM; Phone Number: 86-13335110772; Email: wfk8664@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Cancer Hospital and Institute
      • Contact: Fukai WANG, MM; Phone Number: 13335110772; Email: wfk8664@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
only liver metastasis; There is no other intervention, only clinical treatment.	Drug: 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.	Drug: There is no other intervention, only clinical treatment.; There is no other intervention, only clinical treatment.
only brain; There is no other intervention, only clinical treatment.
No distant metastasis; There is no other intervention, only clinical treatment.	Drug: There is no other intervention, only clinical treatment.; There is no other intervention, only clinical treatment.
More than two organs metastasis; There is no other intervention, only clinical treatment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression of disease	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.	Up to 10 years
overall survival	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.	Up to 10 years

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute
• Investigators: Study Chair: YU Zhiyong, PhD, Shandong Cancer Hospital and Institute; Principal Investigator: WANG Fukai, MM, Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: biomarkers; metabolomics; metastatic breast cancer; Clinical study
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OMICS Mark

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No