Metabolomics Explores Biomarkers for Metastatic Breast Cancer
NCT ID: NCT04302415
Last Updated: 2020-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2019-10-01
2023-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
NCT01492556
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
NCT07019337
Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer
NCT01526512
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy
NCT04258163
A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients
NCT04556292
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
only liver metastasis
There is no other intervention, only clinical treatment.
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.
There is no other intervention, only clinical treatment.
only brain
There is no other intervention, only clinical treatment.
No interventions assigned to this group
No distant metastasis
There is no other intervention, only clinical treatment.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
There is no other intervention, only clinical treatment.
There is no other intervention, only clinical treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Cancer Hospital and Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhiyong Yu
Head of Breast surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
YU Zhiyong, PhD
Role: STUDY_CHAIR
Shandong Cancer Hospital and Institute
WANG Fukai, MM
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OMICS Mark
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.